Methods, systems and devices for non-invasive open ventilation with gas delivery nozzles within nasal pillows

ABSTRACT

A non-invasive ventilation system may include a nasal interface. The nasal interface may include a left outer tube with a left distal end adapted to impinge a left nostril, at least one left opening in the left distal end in pneumatic communication with the left nostril, and a left proximal end of the left outer tube in fluid communication with ambient air. The left proximal end of the left outer tube may curve laterally away from a midline of a face. A right outer tube may be similarly provided. One or more left jet nozzles may direct ventilation gas into the left outer tube, and one or more right jet nozzles may direct ventilation gas into the right outer tube. The jet nozzles may be in fluid communication with the pressurized gas supply.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 61/166,150, filed Apr. 2, 2009, U.S. Provisional PatentApplication No. 61/239,728, filed Sep. 3, 2009, and U.S. ProvisionalPatent Application No. 61/255,760, filed Oct. 28, 2009, and U.S.Provisional Patent Application No. 61/294,363, filed Jan. 12, 2010; thecontents of which are incorporated by reference herein in theirentireties.

FIELD OF THE INVENTION

The present invention relates to the field of ventilation therapy forpersons suffering from respiratory and breathing disorders, such asrespiratory insufficiency and sleep apnea. More specifically, thepresent invention relates to methods and apparatus for non-invasive opennasal interfaces.

BACKGROUND OF INVENTION

There are a range of clinical syndromes that require some form ofventilation therapy. These syndromes may include hypoxemia, variousforms of respiratory insufficiency and airway disorders. There are alsonon-respiratory and non-airway diseases that require ventilationtherapy, such as congestive heart failure and neuromuscular disease,respectively.

Different and separate from ventilation therapy, is oxygen therapy, usedfor less severe forms of respiratory insufficiency. The standard of carefor oxygen therapy or long term oxygen therapy (LTOT) includesadministering supplemental oxygen to the patient with a small bore nasalcannula, using a metering device known as an oxygen conserver thatreleases the oxygen in boluses during a patient's inspiratory phase.This therapy is not considered ventilation therapy or respiratorysupport, because it does not mechanically help in the work of breathing.

Some entrainment mask systems have been developed and used for thepurpose of delivering proper mixtures of air and therapeutic gas. Forexample, oxygen reservoir systems exist that include a mask with portsto entrain room air. Or, high flow oxygen delivery systems exist thatinclude an air-entrainment mask containing a jet orifice and airentrainment ports, are designed to fit over the patient's nose andmouth, and connect to oxygen supply tubing. Oxygen under pressure isforced through a small jet orifice entering the mask. The velocityincreases causing a shearing effect distal to the jet orifice, whichcauses room air to be entrained into the mask. These oxygen therapyentrainment systems do not support the work of breathing of the patient,rather they are used to deliver proper mixtures of air and oxygen.

Recently, a variant of oxygen therapy has been employed, known as highflow oxygen therapy (HFOT). In this case, the oxygen flow rate isincreased beyond standard LTOT, for example, above 10 LPM. Because ofthe high flow rate, the oxygen must be humidified to prevent drying outthe patient's airway. It has been reported that HFOT can reduce thepatient's pleural pressure during spontaneous breathing. These systemsare inefficient in that they are not precise in delivery of the therapy,and they consume a significant quantity of oxygen, which is often adrawback because the system cannot be mobile.

Respiratory support and ventilation therapies provide mechanicalventilation (MV) to the patient, and mechanically contribute to the workof breathing. MV therapies interface with the patient by intubating thepatient with a cuffed or uncuffed tracheal tube, or a sealing face mask,sealing nasal mask or sealing nasal cannula. While helpful in supportingthe work of breathing, the patient interfaces used for MV are obtrusiveand/or invasive to the user, and MV does not facilitate mobility oractivities of daily living and is therefore a drawback to many potentialusers.

Non-invasive ventilation (NIV) is used to ventilate a patient withoutrequiring intubation. This is a significant advantage in that thepatient does not require sedation for the therapy. However, the patientcannot use their upper airway because the interface makes an externalseal against the nose and/or mouth, and the system is not mobile, thecombination of which does not enable activities of daily living.

Minimally invasive ventilation (MIV) has been described to ventilate apatient with a catheter based delivery system that does not close theairway, and the patient can breathe ambient air freely and naturallythrough their normal passage ways. MIV differs from NIV because in NIVthe patient interface does not enter the person's body, or minimallyenters the body, and no unnatural channels are required to gain accessto the airway, whereas MIV requires a slightly penetrating catheter orinterface into an airway, and/or requires an unnatural channel to becreated for airway access. MIV therapies have some promise; however, thepatient needs to tolerate a transcutaneous catheter, for example apercutaneous transtracheal catheter, which can be beneficial for thosewhom are already trached or for those whom wish to conceal the interfaceunderneath clothing.

For treating obstructive sleep apnea (OSA), the gold standardventilation therapy is continuous positive airway pressure (CPAP) orbilevel positive airway pressure (BiPAP), which is a variant to NIV inthat the patient partially exhales through exhaust ports in the mask andexhales the balance back into the large deadspace mask and large gasdelivery tubing. The continuous positive pressure being applied from theventilator opens the upper airway, using a patient interface mask thatseals over the nose and or mouth, or seals inside the nose. While highlyeffective in treating OSA, this therapy has poor patient compliancebecause the patient interface is obtrusive to the patient, and becausethe patient unnaturally breathes through a mask and gas deliverycircuit. A lesser obtrusive BiPAP and CPAP patient interface has beendescribed by Wondka (U.S. Pat. No. 7,406,966), which is used for bothNIV and OSA, in which the interface is low profile and allows for anadjustable fitment and alignment with the user's face and nose. Theinterface solves many of the preexisting problems associated with NIVmasks and OSA masks, namely leaks, comfort, tolerance, sleep position,pressure drop and noise, and compatibility with a variety of anatomicalshapes.

In summary, existing therapies and prior art have the followingdisadvantages: they do not offer respiratory support or airway supportin a manner that (1) is non-invasive, and un-obtrusive such that itallows for mobility and activities of daily living, (2) allows thesensation of breathing from the ambient surroundings normally, and (3)is provided in an easily portable system or a system that can be easilyborne or worn by the patient.

SUMMARY OF INVENTION

The invention may provide ventilation to a patient using non-invasiveopen ventilation (NIOV) with a non-invasive nasal interface that doesnot completely cover or seal the opening of the patient's mouth or nose.The invention can be used to treat respiratory insufficiency byproviding MV to support the work of breathing of a patient, or can beused to treat OSA by pressurizing or providing flow to the airway. Thenasal interface may include a novel jet pump nasal catheter design, withthe nozzle of the catheter positioned near the entrance of the nostrils,and designed with a geometric configuration which optimizes the fluiddynamics of the system to improve the efficiency of the system andefficacy of the therapy. A pressurized gas, such as a therapeutic gaslike oxygen-rich gas or simply pressurized air, may be delivered throughthe catheter, and when exiting the catheter distal tip, may entrain anamount of ambient air that is 25-250% of the gas exiting the catheterdue to the configuration of the catheter, so that a combination ofventilator-delivered gas and entrained gas is delivered to the patient.Embodiments of the present invention can, for example, create anincrease of 2-40 cmH2O in the upper airway, and 1-30 cmH2O in the lung.A ventilator-delivered gas volume of 50 ml can entrain for example 50ml, so that 100 ml is delivered to the patient, with a sufficientdriving pressure so that a significant amount of the 100 ml volumereaches the airway or lung to increase pressure in those areas, thusmechanically supporting respiration, or preventing airway collapse. Inthe subsequent descriptions, nasal cannula, nasal catheter, jet nozzle,and ventilation interface are often used interchangeably when pertainingto the present invention. Also, jet nozzle, gas delivery port and gasexit port may be used interchangeably in the invention.

A non-invasive ventilation system may include an interface. Theinterface may include at least one gas delivery jet nozzle adapted to bepositioned in free space and aligned to directly deliver ventilation gasinto an entrance of a nose. The at least one gas delivery jet nozzle maybe connected to a pressurized gas supply. The ventilation gas mayentrain ambient air to elevate lung pressure, elevate lung volume,decrease the work of breathing or increase airway pressure, and whereinthe ventilation gas is delivered in synchrony with phases of breathing.A support for the at least one gas delivery jet nozzle may be provided.A breath sensor may be in close proximity to the entrance of the nose. Apatient may spontaneous breathe ambient air through the nose withoutbeing impeded by the interface.

The support may be a connector for coupling the system to a bridge ofthe nose and aligning the at least one gas delivery jet nozzle with theentrance of the nose. A gas delivery circuit may pass along one side ofa face. A sensing tube may pass along an opposite side of the face. Theconnector may be a shell. The support may be a bracket. The support maybe a skin pad between the nose and mouth. The at least one jet nozzlemay be outside the entrance to the nose. The at least one jet nozzle maybe substantially flush with the entrance to the nose. The at least onejet nozzle may be inside the entrance to the nose. The at least one jetnozzle may be positioned approximately 0 inches to approximately 1.5inches outside the entrance to the nose. The at least one jet nozzle maybe positioned within approximately 10 degrees of parallel with theentrance to the nose. Ventilation gas may be delivered duringinspiration. The at least one jet nozzle may be aligned with apositioning arm. The at least one jet nozzle may be integrated with amanifold. The support may be a gas delivery circuit and a sensing tube.The support may be a headset. At least one sensor may be within themanifold. A sound baffle may be provided. A wearable ventilator and aportable gas supply may be provided. A ventilator may be provided wherethe ventilator includes a control unit, wherein the control unit adjustsan output of the ventilator to match a patient's needs based oninformation from the breath sensor. The system further may include aventilator, the ventilator may include a control unit, and the controlunit may include a speaking mode sensing system, and wherein the controlunit adjusts an output of the ventilator while a patient is speaking tonot be asynchronous with a patient's spontaneous breathing. The systemmay include a ventilator, the ventilator may include a control unit, andthe control unit may include an apnea or hypopnea sensing system, andwherein the control unit adjusts an output of the ventilator accordingto apnea or hypopnea.

A non-invasive ventilation system may include a ventilator; a controlunit; a gas delivery circuit in fluid communication with the ventilator;a sensing tube in communication with the control unit; a shell forcoupling to a bridge of a nose; a connector for coupling the gasdelivery circuit and the sensing tube to the shell; and one or morenozzles at a distal end of the gas delivery circuit, wherein the one ormore nozzles are positioned in free space below an entrance to one ormore nostrils, and wherein the one or more nozzles are aligned with theentrance to the one or more nostrils.

The system may include a ledge for contacting a rim of the one or morenostrils and positioning the system. The ledge may include a sensingport connected to the sensing tube. The system may include a portablegas supply, and wherein ventilator is wearable. The control unit mayadjust an output of the ventilator to match a patient's needs based oninformation from the sensing tube. The control unit may include aspeaking mode sensing system, and wherein the control unit adjusts anoutput of the ventilator while a patient is speaking to not beasynchronous with a patient's spontaneous breathing. The control unitmay include an apnea or hypopnea sensing system, and wherein the controlunit adjusts an output of the ventilator according to apnea or hypopnea.

A method for providing respiratory support may include providing anon-invasive ventilation system including a ventilator; a gas deliverycircuit; at least one jet nozzle positioned in free space and aligned todirectly deliver ventilation gas into an entrance of a nose; at leastone sensor; and a support for the at least one jet nozzle. The methodmay include measuring spontaneous respiration with the at least onesensor placed in close proximity to the nostril; and activating theventilator to supply ventilation gas in synchrony with phases ofbreathing through the gas delivery circuit and to the at least one jetnozzle such that the ventilation gas entrains ambient air. Theventilation gas may entrain ambient air to elevate lung pressure,elevate lung volume, decrease the work of breathing or increase airwaypressure.

The at least one jet nozzle may be outside the entrance to the nose. Theat least one jet nozzle may be positioned approximately 0 inches toapproximately 1.5 inches outside the entrance to the nose. The at leastone jet nozzle may be positioned within approximately 10 degrees ofparallel with the entrance to the nose. The at least one jet nozzle maybe within a manifold. The non-invasive ventilation system may alsoinclude a portable gas supply where the ventilator is wearable. Thesupply of ventilation gas may be adjusted to meet the needs of a patientbased on information from the at least one sensor. The method may alsoinclude detecting speaking where the supply of ventilation gas isadjusted based on whether or not a patient is speaking. The method mayalso include detecting apnea or hypopnea where the supply of ventilationgas is adjusted based on apnea or hypopnea.

A non-invasive ventilation system may include at least one outer tubewith a proximal lateral end of the outer tube adapted to extend to aside of a nose. The at least one outer tube may also include a throatsection. At least one coupler may be located at a distal section of theouter tube for impinging at least one nostril and positioning the atleast one outer tube relative to the at least one nostril. At least onejet nozzle may be positioned within the outer tube at the proximallateral end and in fluid communication with a pressurized gas supply. Atleast one opening in the distal section may be adapted to be in fluidcommunication with the nostril. At least one aperture in the at leastone outer tube may be in fluid communication with ambient air. The atleast one aperture may be in proximity to the at least one jet nozzle.

The outer tube may include a first outer tube and a second outer tubeextending in substantially opposite directions. At least one jet nozzlemay be positioned within the first outer tube and at least one jetnozzle may be positioned within the second outer tube. The first outertube may be separated from the second outer tube by a divider. The atleast one outer tube may be a manifold. A gas flow path may be withinthe manifold may be curved and devoid of abrupt angles and corners. Atleast one coupler may be a nasal pillow. At least one coupler may sealthe nostril such that a patient spontaneously breathes through the atleast one aperture. The distal tip of the at least one jet nozzle may bepositioned at the at least one aperture. The at least one jet nozzle maydirect pressurized gas in a substantially parallel direction withambient air entering from the at least one aperture. At least onesecondary aperture may be in the outer tube. The at least one jet nozzlemay direct pressured gas coaxially to a primary gas flow pathway. Afilter may be included. At least one gas flow path may be includedthrough the outer tube, and pressurized gas may be directed toward awall of the gas flow path. At least one sensor may be provided forsensing spontaneous respiration. A ventilator may deliver pressurizedgas in synchrony with phases of breathing. A cross sectional area of theat least one aperture may be larger than a cross sectional area of thethroat section. A wearable ventilator and a portable gas supply may beprovided. A ventilator may be provided, the ventilator may include acontrol unit, and wherein the control unit adjusts an output of theventilator to match a patient's ventilation needs based on informationfrom at least one sensor. A ventilator may be provided, the ventilatormay include a control unit, and the control unit may include a speakingmode sensing system, and wherein the control unit adjusts an output ofthe ventilator while the patient is speaking to not be asynchronous witha patient's spontaneous breathing. A ventilator may be provided, theventilator may include a control unit, and the control unit may includean apnea or hypopnea sensing system, and wherein the control unitadjusts an output of the ventilator according to apnea or hypopnea. Theouter tube may include sound reduction features selected from the groupconsisting of: a secondary aperture, a filter for the aperture, texturedsurfaces, a muffler, sound absorbing materials, an angled jet nozzle,non-concentric jet nozzle positions, and combinations thereof.

A non-invasive ventilation system may include a ventilator; a gasdelivery circuit in fluid communication with the ventilator, wherein thegas delivery circuit is bifurcated; a manifold in fluid communicationwith the ventilator, wherein each lateral proximate end of the manifoldis in fluid communication with the gas delivery circuit; a gas deliverypath from each lateral proximal end of the manifold to a distal end ofthe manifold; at least one aperture in each lateral proximal end of themanifold between the gas delivery path and ambient air; at least one jetnozzle within each gas delivery path and aligned in parallel with eachgas delivery path, wherein the at least one jet nozzle suppliesventilation gas proximate to the at least one aperture; tubularextensions at the distal end of the manifold, wherein the tubularextensions comprise a throat section; and a septum separating each gasdelivery path.

The system may include at least one sensor. The tubular extensions mayinclude nasal cushions. The ventilation gas and entrained ambient airmay elevate lung pressure, elevate lung volume, decrease work ofbreathing or increase airway pressure. A cross sectional area of the atleast one aperture may be larger than a cross sectional area of thethroat section. A portable gas supply may be provided, and theventilator may be portable. The ventilator may include a control unit,and the control unit may adjust an output of the ventilator to match apatient's ventilation needs based on information from at least onesensor. The ventilator may include a control unit, and the control unitmay include a speaking mode sensing system, and the control unit mayadjust an output of the ventilator while a patient is speaking to not beasynchronous with a patient's spontaneous breathing. The ventilator mayinclude a control unit, and the control unit may include an apnea orhypopnea sensing system, and the control unit may adjust an output ofthe ventilator according to apnea or hypopnea. The manifold may includesound reduction features selected from the group consisting of: asecondary aperture, a filter for the aperture, textured surfaces, amuffler, sound absorbing materials, an angled jet nozzle, non-concentricjet nozzle positions, and combinations thereof.

A method of providing respiratory support may include providing anon-invasive ventilation system including a ventilator; a gas deliverycircuit; an outer tube; at least one gas delivery path through the outertube; at least one aperture between the at least one gas delivery tubeand ambient air, wherein the at least one aperture is at a proximallateral end of the at least one gas delivery path; at least one jetnozzle within the gas delivery path proximate to the at least oneaperture; at least one sensor; and at least one nasal cushion at adistal end of the outer tube for impinging a nostril. The method mayinclude measuring spontaneous respiration with the at least one sensor;and activating the ventilator to supply ventilation gas in synchronywith phases of breathing through the gas delivery circuit and to the atleast one jet nozzle such that the ventilation gas entrains ambient air,wherein the ventilation gas entrains ambient air.

The ventilation gas and entrained ambient air may elevate lung pressure,elevate lung volume, decrease work of breathing or increase airwaypressure. The non-invasive ventilation system may include a portable gassupply, where the ventilator is wearable. The supply of ventilation gasmay be adjusted to meet the needs of a patient based on information fromthe at least one sensor. The method may include detecting speaking, andthe supply of ventilation gas may be adjusted based on whether or not apatient is speaking. The method may include detecting apnea or hypopnea,and the supply of ventilation gas may be adjusted based on apnea orhypopnea.

A non-invasive ventilation system may include a nasal interface. Thenasal interface may include a left outer tube with a left distal endadapted to impinge a left nostril, at least one left opening in the leftdistal end in pneumatic communication with the left nostril, and a leftproximal end of the left outer tube in fluid communication with ambientair. The left proximal end of the left outer tube may curve laterallyaway from a midline of a face. A right outer tube may be similarlyprovided. One or more left jet nozzles may direct ventilation gas intothe left outer tube, and one or more right jet nozzles may directventilation gas into the right outer tube. The jet nozzles may be influid communication with the pressurized gas supply.

The one or more left jet nozzles, the one or more right jet nozzles, orboth may be directed toward an inner wall of the left outer tube, theright outer tube, or both. The left outer tube and the right outer tubemay include a jet pump throat and a jet pump diffuser. The one or moreleft jet nozzles may be flush with an entrance of the left outer tubeand the one or more right jet nozzles may be flush with an entrance ofthe right outer tube. The one or more left jet nozzles may be within anentrance of the left outer tube and the one or more right jet nozzlesmay be within an entrance of the right outer tube. The one or more leftjet nozzles may be outside an entrance of the left outer tube and theone or more right jet nozzles may be outside an entrance of the rightouter tube. The system may include at least one sensing lumen, and/or atleast one secondary sensing lumen, and/or a drug delivery lumen, and/ora humidity delivery lumen, and/or a coupler between the left outer tubeand the right outer tube. A ventilator may deliver ventilation gas insynchrony with phases of breathing. Ambient air may be entrained throughthe outer tube. The ventilation gas and the entrained ambient air mayelevate lung pressure, elevate lung volume, decrease work of breathingor increase airway pressure. The left outer tube and the right outertube may be stabilized against a face. A wearable ventilator and aportable gas supply may be provided. A ventilator may be provided, theventilator may include a control unit, and wherein the control unit mayadjust an output of the ventilator to match a patient's needs based oninformation from at least one sensor. A ventilator may be provided, theventilator may include a control unit, the control unit may include aspeaking mode sensing system, and wherein the control unit may adjust anoutput of the ventilator while the patient is speaking to not beasynchronous with a patient's spontaneous breathing. A ventilator may beprovided, the ventilator may include a control unit, the control unitmay include an apnea or hypopnea sensing system, and wherein the controlunit adjusts an output of the ventilator based on apnea or hypopnea. Theleft outer tube or the right outer tube may include sound reductionfeatures selected from the group of: a secondary aperture, a filter forthe aperture, textured surfaces, a muffler, sound absorbing materials,an angled jet nozzle, non-concentric jet nozzle positions, andcombinations thereof.

A non-invasive ventilation system may include a ventilator; a gasdelivery circuit comprising a left gas path and a right gas path; and anasal interface comprising a left outer tube receiving ventilation gasfrom at least one nozzle on a distal end of the left gas path and aright outer tube receiving ventilation gas from at least one nozzle on adistal end of the right gas path; wherein the left outer tube and theright outer tube curve laterally away from a midline of a nose.

Ventilation gas may be directed toward an inner wall of the left outertube and the right outer tube. The at least one nozzle on the distal endof the left gas path may be within the left outer tube and the at leastone nozzle on the distal end of the right gas path may be within theright outer tube. The at least one nozzle on the distal end of the leftgas path may be flush with the left outer tube and the at least onenozzle on the distal end of the right gas path may be flush with theright outer tube. The at least one nozzle on the distal end of the leftgas path may be outside the left outer tube and the at least one nozzleon the distal end of the right gas path may be outside the right outertube. The left gas path and the right gas path may be stabilized againsta face. A portable gas supply may be provided, and the ventilator may beportable. The ventilator may include a control unit, and the controlunit may adjust an output of the ventilator to match a patient's needsbased on information from at least one sensor. The ventilator mayinclude a control unit, the control unit may include a speaking modesensing system, and the control unit may adjust an output of theventilator while the patient is speaking to not be asynchronous with apatient's spontaneous breathing. The ventilator may include a controlunit, the control unit may include an apnea or hypopnea sensing system,and the control unit may adjust an output of the ventilator based onapnea or hypopnea. The left gas path or the right gas path may includesound reduction features selected from the group of: a secondaryaperture, a filter for the aperture, textured surfaces, a muffler, soundabsorbing materials, an angled jet nozzle, non-concentric jet nozzlepositions, and combinations thereof.

A method of providing ventilation gas may include providing a nasalinterface system including a ventilator; a gas delivery circuit; atleast one jet nozzle at a distal end of the gas delivery circuit; atleast one outer tube proximate to the distal end of the gas deliverycircuit for receiving ventilation gas from the at least one jet nozzle,and wherein the at least one outer tube curves laterally away from amidline of a nose; at least one sensor; measuring spontaneousrespiration with the at least one sensor; and activating the ventilatorto supply ventilation gas in synchrony with phases of breathing throughthe gas delivery circuit and to the at least one jet nozzle such thatthe ventilation gas entrains ambient air, wherein the ventilation gasentrains ambient air.

The ventilation gas and entrained ambient air may elevate lung pressure,elevate lung volume, decrease work of breathing or increase airwaypressure. Ventilation gas may be directed toward an inner wall of the atleast one outer tube. The at least one nozzle may be within the at leastone outer tube. The at least one nozzle may be flush with the at leastone outer tube. The at least one nozzle may be outside the at least oneouter tube. The nasal interface system may include a portable gassupply, where the ventilator is portable. The supply of ventilation gasmay be adjusted to meet the needs of a patient based on information fromthe at least one sensor. The method may include detecting speaking, andthe supply of ventilation gas may be adjusted based on whether or not apatient is speaking. The method may include detecting apnea or hypopnea,and the supply of ventilation gas may be adjusted based on apnea orhypopnea.

A system for providing ventilation support to a patient may include aventilator, a control unit, a gas delivery circuit with a proximal endin fluid communication with the ventilator and a distal end in fluidcommunication with a nasal interface, and a nasal interface. The nasalinterface may include at least one jet nozzle at the distal end of thegas delivery circuit; and at least one spontaneous respiration sensorfor detecting respiration in communication with the control unit. Thesystem may be open to ambient. The control unit may receive signals fromthe at least one spontaneous respiration sensor and determine gasdelivery requirements. The ventilator may deliver gas at a velocity toentrain ambient air and increase lung volume or lung pressure abovespontaneously breathing levels to assist in work of breathing, anddeliver ventilation gas in a cyclical delivery pattern synchronized witha spontaneous breathing pattern.

The at least one jet nozzle may be adapted to be positioned in freespace and may be aligned to directly deliver ventilation gas into anentrance of a nose. The nasal interface may include a support for the atleast one jet nozzle. A patient may spontaneous breathe ambient airthrough the nose. The nasal interface may include at least one outertube with a proximal lateral end of the outer tube adapted to extendtoward a side of a nose; at least one coupler at a distal section of theouter tube for impinging at least one nostril and positioning the atleast one outer tube relative to the at least one nostril; at least oneopening in the distal section adapted to be in fluid communication withthe nostril; and at least one aperture in the at least one outer tube influid communication with ambient air, wherein the at least one apertureis in proximity to the at least one jet nozzle, and wherein the at leastone jet nozzle is positioned within the outer tube at the proximallateral end and in fluid communication with a pressurized gas supply.The at least one coupler may be a nasal cushion. The nasal interface mayinclude a left outer tube comprising a left distal end adapted toimpinge a left nostril, at least one left opening in the left distal endin pneumatic communication with the left nostril, a left proximal end ofthe left outer tube in fluid communication with ambient air, and whereinthe left proximal end of the left outer tube curves laterally away froma midline of a face; and a right outer tube comprising a right distalend adapted to impinge a right nostril, at least one right opening inthe right distal end in pneumatic communication with the right nostril,a right proximal end of the right outer tube in fluid communication withambient air, and wherein the right proximal end of the right outer tubecurves laterally away from the midline of the face. Ambient air may beentrained through the left outer tube or the right outer tube.Ventilation gas may be provided at the beginning of respiration.Ventilation gas may be provided by ramping. The control unit may adjustan output of the ventilator to match a patient's needs based oninformation from the at least one respiration sensor. The control unitmay include a speaking mode sensing system, and the control unit mayadjust an output of the ventilator while the patient is speaking to notbe asynchronous with the patient's spontaneous breathing. The nasalinterface may include an outer tube, and wherein the outer tubecomprises sound reduction features selected from the group consistingof: a secondary aperture, a filter for the aperture, textured surfaces,a muffler, sound absorbing materials, an angled jet nozzle,non-concentric jet nozzle positions, and combinations thereof.

A device for providing ventilatory support to a patient may include aventilator with a control system; a gas supply; a nasal interface opento ambient comprising at least one jet nozzle and at least one breathingsensor; and a gas delivery circuit pneumatically connecting theventilator to the at least one jet nozzle for delivering ventilationgas, and wherein the nasal interface is adapted to locate the at leastone breathing sensor in proximity to a nostril entrance, and is adaptedto locate the at least one jet nozzle a distance away from the nostrilentrance distal to the at least one breathing sensor.

The ventilator may deliver ventilation gas at a velocity to entrainambient air and increase lung volume or lung pressure abovespontaneously breathing levels to assist in work of breathing. Theventilator may deliver ventilation gas in a cyclical delivery patternsynchronized with a spontaneous breathing pattern. The at least one jetnozzle may be adapted to be positioned in free space and may be alignedto directly deliver ventilation gas into an entrance of a nose. Thenasal interface may include a support for the at least one jet nozzle. Apatient may spontaneous breathe ambient air through the nose. The nasalinterface may include at least one outer tube with a proximal lateralend of the outer tube adapted to extend toward a side of a nose; atleast one coupler at a distal section of the outer tube for impinging atleast one nostril and positioning the at least one outer tube relativeto the at least one nostril; at least one opening in the distal sectionadapted to be in fluid communication with the nostril; and at least oneaperture in the at least one outer tube in fluid communication withambient air, wherein the at least one aperture is in proximity to the atleast one jet nozzle, and wherein the at least one jet nozzle ispositioned within the outer tube at the proximal lateral end and influid communication with a pressurized gas supply. The at least onecoupler may be a nasal cushion. The nasal interface may include a leftouter tube comprising a left distal end adapted to impinge a leftnostril, at least one left opening in the left distal end in pneumaticcommunication with the left nostril, a left proximal end of the leftouter tube in fluid communication with ambient air, and wherein the leftproximal end of the left outer tube curves laterally away from a midlineof a face; and a right outer tube comprising a right distal end adaptedto impinge a right nostril, at least one right opening in the rightdistal end in pneumatic communication with the right nostril, a rightproximal end of the right outer tube in fluid communication with ambientair, and wherein the right proximal end of the right outer tube curveslaterally away from the midline of the face. Ambient air may beentrained through the left outer tube or the right outer tube.Ventilation gas may be provided at the beginning of respiration.Ventilation gas may be provided by ramping. The control unit may adjustan output of the ventilator to match a patient's needs based oninformation from the at least one respiration sensor. The control unitmay include a speaking mode sensing system, and the control unit mayadjust an output of the ventilator while the patient is speaking to notbe asynchronous with the patient's spontaneous breathing. The nasalinterface may include an outer tube, and wherein the outer tubecomprises sound reduction features selected from the group consistingof: a secondary aperture, a filter for the aperture, textured surfaces,a muffler, sound absorbing materials, an angled jet nozzle,non-concentric jet nozzle positions, and combinations thereof.

A method for providing ventilation support may include providing a nasalinterface for positioning at least one jet nozzle; deliveringventilation gas from a ventilator to a gas delivery circuit in fluidcommunication with the at least one jet nozzle; delivering ventilationgas to a patient nasal airway through the at least one jet nozzle;sensing spontaneous respiration with at least one sensor incommunication with a control unit; determining ventilation gas deliveryrequirements; modifying the delivery of ventilation gas based uponphases of breathing in a cyclical pattern synchronized with the phasesof breathing; wherein the ventilation gas increases lung volume or lungpressure above spontaneously breathing levels to assist in work ofbreathing, wherein the ventilation gas entrains ambient air, and whereinthe patient nasal airway is open to ambient.

The at least one jet nozzle may be adapted to be positioned in freespace and may be aligned to directly deliver the ventilation gas into anentrance of a nose. The nasal interface may include a support for the atleast one jet nozzle. The nasal interface may include at least one outertube with a proximal lateral end of the outer tube adapted to extendtoward a side of a nose; at least one coupler at a distal section of theouter tube for impinging at least one nostril and positioning the atleast one outer tube relative to the at least one nostril; at least oneopening in the distal section adapted to be in fluid communication withthe nostril; and at least one aperture in the at least one outer tube influid communication with ambient air, wherein the at least one apertureis in proximity to the at least one jet nozzle, and wherein the at leastone jet nozzle is positioned within the outer tube at the proximallateral end and in fluid communication with a pressurized gas supply.The at least one coupler may be a nasal cushion. The nasal interface mayinclude a left outer tube comprising a left distal end adapted toimpinge a left nostril, at least one left opening in the left distal endin pneumatic communication with the left nostril, a left proximal end ofthe left outer tube in fluid communication with ambient air, and whereinthe left proximal end of the left outer tube curves laterally away froma midline of a face; and a right outer tube comprising a right distalend adapted to impinge a right nostril, at least one right opening inthe right distal end in pneumatic communication with the right nostril,a right proximal end of the right outer tube in fluid communication withambient air, and wherein the right proximal end of the right outer tubecurves laterally away from the midline of the face. Ambient air may beentrained through the left outer tube or the right outer tube.Ventilation gas may be provided at the beginning of respiration.Ventilation gas may be provided by ramping. The nasal interface may beadapted to locate the at least one sensor in proximity to a nostrilentrance, and may be adapted to locate the at least one jet nozzle adistance away from the nostril entrance distal to the at least onesensor. The method may include providing a portable gas supply where theventilator is wearable. The supply of ventilation gas may be adjusted tomeet the needs of a patient based on information from the at least onesensor. The method may include detecting speaking where the supply ofventilation gas may be adjusted based on whether or not a patient isspeaking.

A system for reducing airway obstructions of a patient may include aventilator, a control unit, a gas delivery circuit with a proximal endin fluid communication with the ventilator and a distal end in fluidcommunication with a nasal interface, and a nasal interface. The nasalinterface may include at least one jet nozzle, and at least onespontaneous respiration sensor in communication with the control unitfor detecting a respiration effort pattern and a need for supportingairway patency. The system may be open to ambient. The control unit maydetermine more than one gas output velocities. The more than one gasoutput velocities may be synchronized with different parts of aspontaneous breath effort cycle, and a gas output velocity may bedetermined by a need for supporting airway patency.

The at least one jet nozzle may be adapted to be positioned in freespace and may be aligned to directly deliver pressurized gas into anentrance of a nose. The nasal interface may include a support for the atleast one jet nozzle. A patient may spontaneous breathe ambient airthrough the nose. The nasal interface may include at least one outertube with a proximal lateral end of the outer tube adapted to extendtoward a side of a nose; at least one coupler at a distal section of theouter tube for impinging at least one nostril and positioning the atleast one outer tube relative to the at least one nostril; and at leastone opening in the distal section adapted to be in fluid communicationwith the nostril; and at least one aperture in the at least one outertube in fluid communication with ambient air, wherein the at least oneaperture is in proximity to the at least one jet nozzle, wherein the atleast one jet nozzle is positioned within the outer tube at the proximallateral end and in fluid communication with a pressurized gas supply.The at least one coupler may be a nasal cushion. The nasal interface mayinclude a left outer tube comprising a left distal end adapted toimpinge a left nostril, at least one left opening in the left distal endin pneumatic communication with the left nostril, a left proximal end ofthe left outer tube in fluid communication with ambient air, and whereinthe left proximal end of the left outer tube curves laterally away froma midline of a face; and a right outer tube comprising a right distalend adapted to impinge a right nostril, at least one right opening inthe right distal end in pneumatic communication with the right nostril,a right proximal end of the right outer tube in fluid communication withambient air, and wherein the right proximal end of the right outer tubecurves laterally away from the midline of the face. Ambient air may beentrained through the outer tube. Pressurized gas may be provided at thebeginning of respiration. Pressurized gas may be provided by ramping. Aportable ventilation gas supply may be provided where the ventilator isportable. The control unit may adjust an output of the ventilator tomatch a patient's needs based on information from the at least onerespiration sensor. The control unit may include a speaking mode sensingsystem, and the control unit may adjust an output of the ventilatorwhile the patient is speaking to not be asynchronous with the patient'sspontaneous breathing. The control unit may include an apnea or hypopneasensing system, and the control unit may adjust an output of theventilator based on apnea or hypopnea. The nasal interface further mayinclude an outer tube, and wherein the outer tube comprises soundreduction features selected from the group consisting of: a secondaryaperture, a filter for the aperture, textured surfaces, a muffler, soundabsorbing materials, an angled jet nozzle, non-concentric jet nozzlepositions, and combinations thereof.

A device for treating sleep apnea may include a ventilator with acontrol system; a gas supply; a nasal interface comprising a manifoldadapted to be placed under the nose, the manifold may include a gas flowpath; a gas chamber in the gas flow path; tubular nasal cushions adaptedto be in communication with the nostril gas flow path and incommunication with the manifold gas flow path; a pressure sensing portin communication with the gas chamber; a spontaneous breathing aperturein communication with the gas flow path wherein the patient can exhalecompletely through the spontaneous breathing aperture, and inspirethrough the spontaneous breathing aperture; and a jet gas deliverynozzle in communication with the gas delivery circuit and incommunication with the manifold gas flow path; and a gas deliverycircuit pneumatically connecting the ventilator to the nasal interface;wherein gas flows from the ventilator through the gas delivery circuit,out the nozzle into the manifold gas flow path, into the chamber, andthrough the nasal cushions to the nasal airways, and wherein the gasdelivery into the chamber of the manifold creates a positive pressure inthe chamber, and wherein the positive pressure is controlled at adesired positive pressure by the control system.

The nose may be in fluid communication with ambient air. The controlsystem may determine more than one gas output velocities, wherein themore than one gas output velocities are synchronized with differentparts of a spontaneous breath effort cycle, and a gas output velocity isdetermined by a need for supporting airway patency. The control systemmay adjust an output of the ventilator to match a patient's needs basedon information from the pressure sensing port. The control system mayinclude a speaking mode sensing system, and the control system mayadjust an output of the ventilator while the patient is speaking to notbe asynchronous with the patient's spontaneous breathing. The controlsystem may include an apnea or hypopnea sensing system, and the controlsystem may adjust an output of the ventilator based on apnea orhypopnea. The nasal interface may include an outer tube, and wherein theouter tube comprises sound reduction features selected from the groupconsisting of: a secondary aperture, a filter for the aperture, texturedsurfaces, a muffler, sound absorbing materials, an angled jet nozzle,non-concentric jet nozzle positions, and combinations thereof.

A device for treating sleep apnea may include a ventilator with acontrol system; a gas supply; a nasal interface open to ambientcomprising at least one jet nozzle and at least one breathing sensor;and a gas delivery circuit pneumatically connecting the ventilator tothe at least one jet nozzle for delivering ventilation gas, and whereinthe nasal interface is adapted to locate the at least one breathingsensor in proximity to a nostril entrance, and is adapted to locate theat least one jet nozzle a distance away from the nostril entrance distalto the at least one breathing sensor.

The at least one jet nozzle may be adapted to be positioned in freespace and may be aligned to directly deliver ventilation gas into anentrance of a nose. The nasal interface may include a support for the atleast one jet nozzle. A patient may spontaneous breathe ambient airthrough the nose. The nasal interface may include at least one outertube with a proximal lateral end of the outer tube adapted to extendtoward a side of a nose; at least one coupler at a distal section of theouter tube for impinging at least one nostril and positioning the atleast one outer tube relative to the at least one nostril; at least oneopening in the distal section adapted to be in fluid communication withthe nostril; and at least one aperture in the at least one outer tube influid communication with ambient air, wherein the at least one apertureis in proximity to the at least one jet nozzle, and wherein the at leastone jet nozzle is positioned within the outer tube at the proximallateral end and in fluid communication with a pressurized gas supply.

The at least one coupler may be a nasal cushion. The nasal interface mayinclude a left outer tube comprising a left distal end adapted toimpinge a left nostril, at least one left opening in the left distal endin pneumatic communication with the left nostril, a left proximal end ofthe left outer tube in fluid communication with ambient air, and whereinthe left proximal end of the left outer tube curves laterally away froma midline of a face; and a right outer tube comprising a right distalend adapted to impinge a right nostril, at least one right opening inthe right distal end in pneumatic communication with the right nostril,a right proximal end of the right outer tube in fluid communication withambient air, and wherein the right proximal end of the right outer tubecurves laterally away from the midline of the face. Ambient air may beentrained through the left outer tube or the right outer tube.Ventilation gas may be provided at the beginning of respiration.Ventilation gas may be provided by ramping. The control system mayadjust an output of the ventilator to match a patient's needs based oninformation from the pressure sensing port. The control system mayinclude a speaking mode sensing system, and the control system mayadjust an output of the ventilator while the patient is speaking to notbe asynchronous with the patient's spontaneous breathing. The controlsystem may include an apnea or hypopnea sensing system, and the controlsystem may adjust an output of the ventilator based on apnea orhypopnea. The nasal interface may include an outer tube, and the outertube may include sound reduction features selected from the groupconsisting of: a secondary aperture, a filter for the aperture, texturedsurfaces, a muffler, sound absorbing materials, an angled jet nozzle,non-concentric jet nozzle positions, and combinations thereof.

A method for reducing airway obstructions of a patient may include:providing a nasal interface for positioning at least one jet nozzle;delivering pressurized gas from a ventilator to a gas delivery circuitin fluid communication with the at least one jet nozzle; deliveringpressurized gas to a patient nasal airway through the at least one jetnozzle; sensing a respiration effort pattern and a need for supportingairway patency with at least one sensor in communication with a controlunit; determining pressurized gas output velocities, wherein the morethan one gas output velocities are synchronized with different parts ofa spontaneous breath effort cycle, and a gas output velocity isdetermined by a need for supporting airway patency; and modifying thedelivery of pressurized gas based upon phases of breathing in a cyclicalpattern synchronized with the phases of breathing; wherein thepressurized gas increases airway pressure, wherein the pressurized gasentrains ambient air, and wherein the patient nasal airway is open toambient.

The at least one jet nozzle may be adapted to be positioned in freespace and may be aligned to directly deliver the pressurized gas into anentrance of a nose. The nasal interface may include a support for the atleast one jet nozzle. The nasal interface may include at least one outertube with a proximal lateral end of the outer tube adapted to extendtoward a side of a nose; at least one coupler at a distal section of theouter tube for impinging at least one nostril and positioning the atleast one outer tube relative to the at least one nostril; at least oneopening in the distal section adapted to be in fluid communication withthe nostril; and at least one aperture in the at least one outer tube influid communication with ambient air, wherein the at least one apertureis in proximity to the at least one jet nozzle, wherein the at least onejet nozzle is positioned within the outer tube at the proximal lateralend and in fluid communication with a pressurized gas source.

The at least one coupler may be a nasal cushion. The nasal interface mayinclude a left outer tube comprising a left distal end adapted toimpinge a left nostril, at least one left opening in the left distal endin pneumatic communication with the left nostril, a left proximal end ofthe left outer tube in fluid communication with ambient air, and whereinthe left proximal end of the left outer tube curves laterally away froma midline of a face; and a right outer tube comprising a right distalend adapted to impinge a right nostril, at least one right opening inthe right distal end in pneumatic communication with the right nostril,a right proximal end of the right outer tube in fluid communication withambient air, and wherein the right proximal end of the right outer tubecurves laterally away from the midline of the face. Ambient air may beentrained through the outer tube. The pressurized gas may be provided atthe beginning of respiration. The pressurized gas may be provided byramping. A tip of the at least one jet nozzle may be directed toward aninner wall of an outer tube. The nasal interface may include a soundreducer. The method may include turning a pressurized gas source on, andmonitoring for a predetermined time without delivering therapy. Themethod may include, after the predetermined time, activating thepressurized gas source to deliver a therapeutic gas flow. The supply ofventilation gas may be adjusted to meet the needs of a patient based oninformation from the at least one sensor. The method may includedetecting speaking, and the supply of ventilation gas may be adjustedbased on whether or not a patient is speaking. The method may includedetecting apnea or hypopnea, and the supply of ventilation gas may beadjusted based on apnea or hypopnea.

A method of treating sleep apnea may include providing a ventilator, agas delivery circuit, and a nasal interface; connecting a proximal endof the gas delivery circuit to the ventilator; connecting a distal endof the gas delivery circuit to the nasal interface; attaching the nasalinterface to a user's face, wherein the nasal interface allows the userto inhale and exhale ambient air across or through the nasal interfacewithout breathing being restricted; turning ventilator power on causingthe ventilator to enter a mode of patient monitoring without deliveringtherapy; and wherein after a delay after turning the ventilator poweron, at a predetermined time, the ventilator delivers a therapeutic gasflow of ventilation gas to a user's nasal airway through the gasdelivery circuit and the nasal interface.

The therapeutic gas flow may be adjusted to meet the needs of the userbased on information from at least one sensor. The method may includedetecting speaking, and the supply therapeutic gas flow may be adjustedbased on whether or not a patient is speaking. The method may includedetecting apnea or hypopnea, and the therapeutic gas flow may beadjusted based on apnea or hypopnea.

Additional features, advantages, and embodiments of the invention areset forth or apparent from consideration of the following detaileddescription, drawings and claims. Moreover, it is to be understood thatboth the foregoing summary of the invention and the following detaileddescription are exemplary and intended to provide further explanationwithout limiting the scope of the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide a furtherunderstanding of the invention and are incorporated in and constitute apart of this specification, illustrate preferred embodiments of theinvention and together with the detailed description serve to explainthe principles of the invention.

FIG. 1 is a schematic diagram showing an exemplary overall system of anembodiment of the invention.

FIG. 2 shows an exemplary embodiment when NIOV is used to treatrespiratory insufficiency or neuromuscular disease.

FIG. 3 shows an exemplary embodiment when NIOV is used to treat sleepapnea.

FIG. 4 shows a prior art therapy for mechanical ventilation deliveredwith an invasive ET tube interface.

FIG. 5 shows a prior art respiratory support therapy for non-invasiveventilation using a nose mask and using a CPAP or BiPAP ventilationmode.

FIG. 6 shows a prior art therapy for treating OSA.

FIG. 7 shows a prior art conventional oxygen delivery cannula foradministering oxygen therapy.

FIG. 8 shows a side view of an exemplary embodiment of a non-invasiveopen nasal ventilation interface with a cannula tip positioned proximalto the nares or nostril rim opening.

FIG. 9 shows a front view of an exemplary non-invasive open nasalventilation interface with a cannula tip positioned proximal to thenares or nostril rim opening.

FIG. 10 shows a cross-sectional view of an exemplary nasal interfacewith a nozzle outside the nose.

FIG. 11 shows a cross-sectional view of an exemplary nasal interfacewith a nozzle flush with the nose.

FIG. 12 shows a cross-sectional view of an exemplary nasal interfacewith a nozzle inside the nose.

FIG. 13A shows a patient using an embodiment of the invention to providework of breathing support while ambulating.

FIG. 13B shows an exemplary embodiment of a nasal interface used on ahead of a patient.

FIG. 14 illustrates an isometric view of a non-invasive open ventilation(NIOV) nasal interface assembly.

FIG. 15 is a close up rear view of the distal end of the nasal interfaceof FIG. 14.

FIG. 16 illustrates a close up front view of the nasal interface of FIG.14.

FIG. 17 illustrates a close up top view of the nasal interface of FIG.14.

FIG. 18 illustrates a bottom view of the nasal interface of FIG. 14 on apatient with a gas delivery pattern and nasal air pressure sensor.

FIG. 19 shows a variation of the above embodiment in which gas deliveryports may be positioned and aligned below a nose by being coupled to amanifold that is coupled to the end of a nose bridge piece.

FIG. 20 describes a similar version to FIG. 19 in which a nose bridgesupport and a nose bridge piece are more substantial.

FIG. 21 shows a gas delivery circuit and a sensing tube external to anose bridge support and a nose bridge piece.

FIG. 22 shows a more substantial connection between a nose bridge pieceand a manifold, such that they are a unified piece.

FIG. 23 shows a similar configuration to FIG. 22 except a manifold isseparate from the nose bridge piece.

FIG. 24 shows a configuration with a nose bridge piece surroundingnozzles.

FIG. 25 shows an embodiment where a nose bridge piece is located to oneside of a nose, rather than along the midline of the nose.

FIG. 26 shows a gas delivery circuit and nasal airway pressure sensingline may attach to a manifold to help secure the system in place.

FIG. 27 shows a gas delivery nozzle within a manifold, so that themanifold can diffuse and dampen the noise generated by the gas exitingthe nozzles.

FIG. 28 shows a gas delivery conduit routed unilaterally to one side ofthe face to free the opposite side from any objects.

FIG. 29 shows an embodiment similar to FIG. 28 where a nose bridgesupport is held in place by or coupled to glasses.

FIG. 30 shows a unilateral configuration with a sensing tube followingthe path of a gas delivery circuit and held in place with a skin cushionon a nose.

FIG. 31 shows a sensing tube on an opposite side of a face from a gasdelivery circuit.

FIG. 32 shows a sound muffler incorporated into a manifold.

FIG. 33 is a close up anterior view of the embodiment of FIG. 33.

FIG. 34 is a close up posterior view of the embodiment of FIG. 33.

FIG. 35 shows an alternative embodiment of positioning gas deliverynozzles below a nose.

FIG. 36 shows gas delivery tubing and a nose support.

FIG. 37 describes a front view of an embodiment of a distal end of apatient interface.

FIG. 38 shows an embodiment where a left and right cannula may beinterconnected with an air flow path, such as a manifold, and theportion of the nasal interface that includes the distal tip jet nozzlecan extend upward from the manifold.

FIG. 39 shows an alternative embodiment in which the jet nozzles at adistal end of a cannula may be apertures in a superior wall of thecannula, and wherein the cannula is curved laterally to one or bothsides of the nose.

FIG. 40 shows a side view of an embodiment of the invention in which thenasal interface includes a locating device to align and position a tipof the nasal interface correctly, in relation to the nostril foramen.

FIG. 41 shows a front view of this embodiment with a connector betweenopposite sides of the gas delivery circuit.

FIG. 42 shows a cross sectional schematic of the embodiment shown inFIGS. 40 and 41.

FIG. 43 shows a cross sectional schematic view of an embodiment of anasal interface that may include an adjustment feature coupled to anadjustment arm that is used to adjust the position of a nozzle relativeto the nostril.

FIG. 44 shows a cross sectional front view of a right nostril in whichan attachment and positioning pad may be included with the system.

FIG. 45 shows a manifold with anatomically matching curves is described.

FIG. 46 is a close up side-front view of the manifold described in FIG.46, showing the gas delivery nozzles with gas delivery routing, andnasal airway pressure sensing ports with pressure sensing lumens.

FIG. 47 describes an embodiment in which a sound baffle is providedabove gas delivery nozzles on a manifold, so that the sound generated bythe gas exiting the nozzles is muted.

FIGS. 48 and 49 describe rear and front views, respectively, of themanifold shown in FIG. 47.

FIG. 50A describes an embodiment in which a manifold includes gasdelivery nozzles as well as entrainment apertures.

FIG. 50B shows an anterior view of the embodiment shown in FIG. 53A.

FIG. 51A shows describes an embodiment in which a manifold includes gasdelivery nozzles as well as entrainment ports.

FIG. 51B describes an anterior view of the embodiment shown in FIG. 51A.

FIG. 52 shows an embodiment in which a manifold includes gas deliverynozzles recessed in the manifold to help dampen the sound that isgenerated and to position the manifold closer to the nose to reduce theprofile of the nasal interface.

FIG. 53 shows an embodiment in which a manifold includes a pad on theposterior skin side of the manifold to help position and cushion themanifold against the skin and apertures.

FIG. 54 shows an embodiment in which a bracket worn on the user's facemay position nasal airway pressure sensing ports below the nose and gasdelivery nozzles below the nose.

FIG. 55 shows a top view of a manifold of a nasal interface that ispositioned under the nose, and shows gas delivery nozzles and nasalairway pressure sensing ports.

FIG. 56 shows a nasal interface in which a manifold is positioned underthe nose using a head set similar to a hands free microphone.

FIG. 57 shows a posterior view of the embodiment of FIG. 59 off of theuser's head.

FIG. 58 shows an alternative to the embodiment of FIG. 56.

FIG. 59 shows an exemplary embodiment where a manifold may be curved andconfigured to be placed under the nose of the user, and which may extendbilaterally from the midline of the face to the sides of the nose.

FIG. 60 shows a front-bottom view of the manifold of FIG. 59.

FIG. 61A shows a top-front-side view of the manifold of FIG. 59.

FIG. 61B shows a front-side view of the manifold of FIG. 59.

FIG. 62A shows a rear view of the manifold of FIG. 59.

FIG. 62B shows a sectional view of the manifold of FIG. 62A along amid-line A-A showing a gas flow path.

FIG. 63A shows a rear-side view of the manifold of FIG. 59.

FIG. 63B shows a sectional view of the manifold of FIG. 63A along a lineB-B showing an end view of a gas delivery nozzle.

FIG. 64A shows a cross sectional schematic view of an embodiment forfurther reducing noise.

FIG. 64B shows a secondary gas flow aperture is shown.

FIG. 64C shows an alternative secondary gas flow aperture with an innertube, in which the gas pathway is co-axial to the primary gas flowpathway.

FIG. 64D shows an embodiment a filter at an aperture, and optionallyinside the outer tube or manifold.

FIG. 65 describes an alternative embodiment of the invention in which anozzle may be angulated with respect to the axial centerline of an outertube or manifold.

FIG. 66 describes an embodiment in which a manifoldentrainment/breathing aperture may be located at a lateral end of amanifold.

FIG. 67 shows an embodiment in which a manifold may include a leftcurved cannula and a right curved cannula.

FIG. 68 shows a posterior view of the manifold of FIG. 67 with nasalpillows.

FIG. 69 shows an anterior view of the manifold of FIG. 67.

FIG. 70 shows an embodiment in which a manifold may be shorter in leftto right length to reduce the size and profile of the nasal interface.

FIG. 71 shows a posterior view of the manifold of FIG. 70.

FIG. 72 shows an anterior view of the manifold of FIG. 70.

FIG. 73 shows an embodiment in which a manifold has at least oneflattened section on a posterior side of the manifold so that themanifold lays flat against the surface of the skin to help stabilize themanifold in place on the user.

FIG. 74 shows a posterior view of the manifold of FIG. 73.

FIG. 75 shows an anterior view of the manifold of FIG. 73.

FIG. 76 shows an embodiment in which a manifold is narrower in the topto bottom dimension to space the manifold away from the mouth as much aspossible.

FIG. 77 shows a posterior view of the manifold of FIG. 76.

FIG. 78 shows an anterior view of the manifold of FIG. 76.

FIG. 79 shows an embodiment including a manifold, tubular extensions onthe superior side of the manifold to impinge with the nostrils, andentrainment/breathing ports on the inferior side of the manifold inalignment with the nostrils and tubular extensions.

FIG. 80 shows an anterior view of the manifold of FIG. 79.

FIG. 81 shows a cross section through line A-A of the manifold of FIG.80.

FIG. 82 shows an embodiment in which two tubes impinge with the nostrilsat their distal ends and curve laterally and inferiorly away from thenostrils.

FIG. 83 shows a jet pump inlet and entrainment zone that may be formedin a nostril rim and opening, nostril wall, nostril foramen, and/ornasal septum.

FIG. 84 shows an entrainment chamber that may form between the nozzleand the outer tube when the nozzle is partially inserted into the outertube.

FIG. 85 shows that the tip of the nozzle may be substantially flush withthe proximal end of the outer tube.

FIG. 86 shows an overall view of a nasal ventilation interface.

FIG. 87 describes an exemplary cross section of the cannula of the nasalinterface at line A-A indicated in FIG. 86.

FIG. 88 describe a more detailed side view of the distal end of thenasal interface shown in FIG. 86.

FIG. 89 shows a front view of an alternate embodiment of a distal end ofa nasal interface.

FIG. 90 shows a front view of an alternate embodiment of the distal endof the nasal interface.

FIG. 91 describes a front view of an alternate embodiment of the distalend of the nasal interface, similar to the embodiments described inFIGS. 89 and 90.

FIGS. 92 and 93 describe an alternate embodiment of a jet pump portionof the distal end of the nasal interface.

FIGS. 94 and 95 show an alternative embodiment in which the gas deliverynozzles are provided in a manifold that includes compliant nostrilinserts.

FIGS. 96 and 97 show another embodiment in which the gas delivery tubesmay attach to a manifold in a mid-section of the manifold, to generallyalign the gas delivery nozzles with the nostril inserts, rather than thegas delivery tubes attaching to the sides of the manifold.

FIGS. 98 and 99 show an embodiment where a distal tip of the interfaceincludes an inner nozzle and concentric outer tube jet pumpconfiguration.

FIGS. 100 and 101 show an embodiment where a low profile nasal interface10401 may be attached to the exterior of the nose.

FIG. 102 is a block diagram describing an exemplary system of theinvention.

FIG. 103 describes an optional embodiment when the invention is intendedfor hospital or institutional use, in which a gas delivery circuit maybe connected to a blender, which receives pressurized oxygen andpressurized air from the hospital pressurized gas supplies.

FIG. 104 shows that the therapy may use a trans-oral interface.

FIG. 105 shows an embodiment used with an ET tube interface.

FIG. 106 is a system block diagram of the components of a ventilator V.

FIG. 107 describes how the patient's work of breathing may bebeneficially affected by the invention, when the invention is used forlung disease or neuromuscular disease applications.

FIG. 108 graphically illustrates the lung volumes achieved with a nasalinterface of the present invention on actual test subjects.

FIG. 109 graphically illustrates lung volumes achieved with a nasalinterface of the present invention on a test subject using a chestimpedance band to measure and display lung volume.

FIG. 110 graphically illustrates the lung volumes achieved with NIOV ona lung simulator bench model in comparison to conventional ventilation.

FIG. 111 graphically shows NIOV in comparison to oxygen therapy, usingthe lung simulator bench model.

FIG. 112 graphically describes a typical COPD patient's ability toperform a 6 minute walk test using standard oxygen therapy and the NIOVtherapy.

FIG. 113A describes lung pressure generated by NIOV compared to lungpressure generated by a conventional CPAP ventilator.

FIG. 113B describes lung volumes achieved with the NIOV system incomparison to conventional BiPAP.

FIGS. 114-117 compare delivery circuit drive pressure of NIOV to theprior art.

FIGS. 118-121 compare inspiratory phase volume delivery of NIOV to theprior art.

FIGS. 122-125 compare lung pressure of NIOV to the prior art.

FIGS. 126-129 compare typical outer diameter of a delivery circuit ofNIOV to the prior art.

FIGS. 130-153 graphically show different alternative ventilator outputwaveforms of the present invention, and the effect of the ventilatoroutput on the patient's lung mechanics.

FIG. 154 shows a reaction and correction algorithm where the spontaneousbreathing sensor may detect a shift in nasal airflow from a normalairflow signal to a reduced airflow signal.

FIG. 155 shows a preemption algorithm where the breathing sensor detectsa shift in nasal airflow from a normal airflow signal to a reducedairflow signal.

FIG. 156 shows a prevention algorithm where ventilator gas flow isdelivered in synchrony with the patient's spontaneous breathing, andwhen a reduction in airflow occurs due to the onset of an obstruction,the cyclical rate of the ventilator prevents the obstruction from fullydeveloping, and the breathing returns to normal.

FIG. 157 graphically shows the patient and ventilator waveforms over aperiod of time, in which the ventilator is activated during theprecursor to an apnea or during periods of apnea or airway obstruction,and then is deactivated when normal breathing is restored.

FIG. 158 shows that the ventilator output may be increased in responseto a weakening airflow or breathing signal, thus preventing obstructionand restoring normal airflow.

FIG. 159 shows that the ventilator output may switch from a synchronizedcyclical on and off output to delivering a continuous flow betweencycles, when the onset of an obstruction is detected.

FIG. 160 shows that the ventilator may emit a continuous flow orpressure output until the precursor to an apnea is detected, at whichtime the ventilator boosts its output to deliver a greater amplitude ofpressure, flow or volume synchronized with inspiration, while thereduced airflow representing the partial obstruction is present.

FIG. 161 shows that a variable ventilator pressure or continuous flowoutput may be delivered, which ramps to a greater amplitude until thereduced airflow signal is returned to a normal signal, after which time,the ventilator output can ramp down to its baseline value.

FIG. 162 shows that ramping may be conducted during inspiratory phaseonly to make the increase more unnoticeable to the patient.

FIG. 163 shows an algorithm in which non-therapeutic pulses of flow aredelivered in synchrony with the patient's inspiratory effort, in orderto condition or acclimate the patient to the feeling and or sound of thetherapy.

FIG. 164 graphically illustrates in closer detail an optional embodimentof the gas delivery waveform when using an inspiratoryeffort-synchronized therapy.

FIG. 165 shows that NIOV can include speaking detection capability, suchas using airway pressure signal processing or sound or vibrationsensors.

FIG. 166 shows a jet nozzle placed concentric to the nares.

FIG. 167 shows a jet nozzle placed coaxially in nasal pillows.

FIG. 168 shows a jet nozzle a distance from an end of a throat sectionsuch that a jet profile diameter substantially equals the throatentrance diameter.

FIG. 169 shows a jet nozzle a distance from an end of a throat sectionsuch that a jet profile diameter substantially equals the throat exitdiameter.

DETAILED DESCRIPTION OF THE EMBODIMENTS

FIG. 1 is a schematic diagram showing an exemplary overall system 101 ofan embodiment of the invention. A patient may be ventilated withnon-invasive open ventilation (NIOV) using a ventilation gas deliverycircuit 103, an airway pressure sensing line 104, and non-invasive opennasal interface (nasal interface) 105. The nasal interface 105preferably does not seal against the patient's nose such as is typicalwith other ventilation interfaces, and rather leaves the nose open forthe user to breathe normally and freely from the ambient surroundings.Ventilation gas 107 delivered from a ventilator 109 may travel throughthe gas delivery circuit 103 and out one or more gas exit ports 111 inthe nasal interface 105. The ventilation gas 107 may exit at a speedthat entrains ambient air 113, such that the combination of ventilationgas 107, entrained ambient air 113 and spontaneously inhaled air 115, ifthe patient is spontaneously breathing, is delivered to the patient'sairways, such as the nasal cavity 117, oropharyngeal airway 119, trachea121, lung 123 and others, under power to create a clinically efficaciouseffect on the lung and airways. Patent may exhale 116 through the noseor mouth.

The nasal interface 105 geometry and dimensions may optimize the physicsand fluid dynamics of the system to maximize performance, and useracceptable and tolerability. The performance of the system may create anincrease in lung volume, or increase in lung pressure, or reduction inthe work-of-breathing of the user, or increase in airway pressure. Theinvention may be different from oxygen therapy systems that do notprovide mechanical ventilatory support or increases in airway pressure,and is different from conventional ventilation systems that work on aclosed airway principle with a sealing mask that seals around the noseand/or mouth or cuffed airway tube. In embodiments of the presentinvention, a patient may exhale completely through ambient air, whereasin existing systems a patient may exhale through a nasal mask andtubing.

The invention may also be different from existing transtracheal systemsbecause embodiments of the present invention perform better thanexpected. With transtracheal systems, delivered gas must work againstresistance in the lower airway to improve airway pressure and assist inwork of breathing. For a nasal system to achieve the same result, thedelivered gas must work against both the lower airway pressure as in atranstracheal system and upper airway pressure in the nose,oropharyngeal airway, etc. As such, it would not have been expected thata nasal interface could be as effective as a transtracheal system. Theinventors, however, have unexpectedly discovered that a nasal interfacecan provide similar improvements to airway pressure and reductions inwork of breathing using a non-invasive, open nasal interface.

The NIOV ventilation system may also include the ventilator 109 in fluidcommunication with a gas supply or gas generating system 125. Theventilator 109 and/or gas supply or gas generating system 125 may beseparate or in a single device 127. Ventilation gas 107 can be oxygen asin the case of respiratory insufficiency applications, air in the caseof sleep apnea or neuromuscular applications, combinations thereof, orany other clinically beneficial gas. The ventilator 107 may have acontrol unit or system. The ventilator 107 may be powered on and mayhave a delay of a predetermined time prior to supplying ventilation gas.After a predetermined time, the ventilator 107 may deliver gas asneeded, such as in synchrony with a breathing pattern.

A spontaneous breathing respiration sensor 129 may also be used todetect, determine and measure the spontaneous breathing pattern andphases of the patient, as well as apnea or hypopnea events, viacommunication with the ventilation system 127, and also determine andmeasure other patient parameters such as respiratory rate or activitylevel. Using this information, the ventilator 109 may then synchronizeand titrate the therapy to the needs of the patient and to match the gasdelivery with the patient's breathing for maximal comfort andtherapeutic titration.

An additional sensor 131 may be used to detect breathing effort. Theinvention may be used to support the respiration of the patient,including supporting the work of breathing by increasing pressure andvolume in the lung, and can be used for maintaining airway patency ofthe upper airways such as the oropharyngeal airway 119. When using theinvention, the patient breathes normally through their upper airway andthrough their nose, while receiving mechanical support through theinterface. During exhalation, the exhaled gas preferably does not enterthe gas delivery circuit but rather exits the nose or mouth directly toambient air, or through, across or around the nasal interface 105 toambient air. The patient can keep their mouth closed during use forexample during inspiration, to help direct the mechanical support to thelower airways and around the oral cavity 133, base of the tongue 135,palate 137 and esophagus 139, or can use a mouth guard or chin band, ifnecessary. The gas delivery can be delivered cyclically in synchronywith the patient's breath phases, or continuously, or combinationsthereof as will be described in subsequent sections. The patient can usethe therapy while stationary, while being transported, while mobile andactive, or while resting or sleeping. The therapy has homecare,hospital, subacute care, emergency, military, pandemic and transportapplications.

The ventilation control is described in more detail as follows. Theventilation system can be used to provide tidal volume augmentation forspontaneously breathing patients, for example, provide 10-50% of thetidal volume needed by the patient. The ventilation system can also beused to provide significant mechanical support to a spontaneouslybreathing patient, for example provide 25-75% of the tidal volume neededby the patient. The ventilation system can also be used to provide fullsupport or life support for the patient, for example 75-100% of thepatient's tidal volume need. The ventilation system can be a volumeventilator with a volume control or volume assist mode, can have an SIMVmode. The ventilation system can also be a pressure ventilator with apressure control or pressure support mode. For example, a pressure of5-20 centimeters of water pressure (cwp) can be generated in the airwayof the patient continuously or cyclically. In another example, thesystem can produce an inspiratory pressure of 5-20 cwp, and anexpiratory pressure of 2-10 cwp. Expiratory pressure can be created byincreasing the exhalation resistance inherent in the nasal interface, orby the gas delivery jet nozzles delivering the requisite amount of gasflow during expiratory phase, or by the entrainment/spontaneousbreathing aperture resistances being adjusted, or any combination of theabove approaches. Measuring the pressure in or near the nasal interface,as well as measuring gas flow rate going through the nasal interface,typically in the manifold, is performed to help measure and control theventilator to emit and produce the desired gas flow, delivered volume,and/or delivered pressure, as well as to monitor and measure exhalationand other respiratory parameters.

FIG. 2 shows an exemplary embodiment when NIOV is used to treatrespiratory insufficiency or neuromuscular disease. A ventilator 201 canbe borne or worn by a patient 203. A nasal interface 205 may be placeddiscretely on the patient's face and a gas delivery circuit 207 can beplaced discretely on the user's body. A user may operate the ventilationsystem through a user interface 209, which may be located on theventilator 201 or in any suitable location. Because the ventilationsystem contributes to some of the mechanical work required for a personto breathe, the user can be active without suffering from dyspnea,hypoxemia or hypercapnia. The user can benefit from ambulation,activity, and participate in the routine activities of daily living,such as preparing meals, bathing, chores around the house, and leavingthe house for outside activities. Further, the user can communicate,eat, drink and swallow, while receiving mechanical ventilation, asopposed to other ventilation interfaces in which the patient's airway isclosed with an external mask, or sealed internally with a cuffed airwaytube.

FIG. 3 shows an exemplary embodiment when NIOV is used to treat sleepapnea. The patient can be in a supine position as shown, or can besleeping on the side or stomach. A nasal interface 301 and a deliverycircuit 303 may be significantly less obtrusive than conventionaltherapies, and the patient may benefit from the sensation of breathingambient air normally around the nasal interface, since it does not sealthe nose. This minimal obtrusiveness and close-to-natural sensation mayallow the therapy to be better tolerated by the user, resulting inimproved patient adherence and thus a more efficacious therapy. The gasdelivery circuit 303 may be coupled to the nasal interface 301 through acannula 305 and may be secured to the patient with a neck strap 307 orother attachment mechanism.

FIG. 4 shows a prior art therapy for mechanical ventilation. A patient401 may be intubated with an endotracheal tube (ETT) 403 and a cuff 405may be inflated in a trachea 407, thus closing the airway off fromambient air. Ventilation gas may be delivered through a ventilation gascircuit 409 and may be monitored with sensors 411. The patient 401 maybe sedated and their lungs are ventilated with gas being delivered andremoved through the ET tube. This therapy, while highly effective inproviding mechanical support for respiration, is not appropriate for thevast number of patients in whom sedation and complete respiratorysupport is not needed.

FIG. 5 shows a prior art respiratory support therapy for non-invasiveventilation, using a nose mask 501 and typically using a BiPAPventilation mode. NIV is used to breathe for the patient, or can be usedto help the breathing of a patient, in which case the patient'sspontaneous breathing effort triggers the ventilator to deliver thepressure or volume based MV. All of the volume delivered to and from thelungs may be delivered and removed from a ventilation circuit 503 andthe nose mask 501. A similar system can be used for OSA, in which caseexhaust vents 505 are included in the nose mask so that a portion of theexhaled gas is exhaled through the vent ports. NIV, CPAP and BiPAP areclinically very effective for spontaneously breathing patients, however,these modes and therapies do not facilitate activities of daily living,the ventilator cannot be borne by the patient, the patient can notbreathe room air naturally and freely, and the patient's upper airwaycannot function normally and naturally because it is sealed off with theexternal mask seal.

FIG. 6 shows a prior art therapy for treating OSA (Wood, U.S. Pat. No.6,478,026). This system is used to deliver CPAP or BiPAP to the user, byemploying a large bore cannula 601 that seals against the user'snostrils 603. Extensions 605 on the large bore cannula 601 extend intothe nostrils to seal the nose. This system has similar drawbacksmentioned associated with NIV, plus has additional drawbacks of comfortand tolerance with the user's face and nose.

FIG. 7 shows a prior art conventional oxygen delivery cannula 701 foradministering oxygen therapy. Extensions 705 on the cannula 701 may beconfigured to enter nares 703. The proximal end of the cannula 701 maybe connected to an oxygen delivery device that can deliver continuousflow oxygen at 1-6 LPM to the user's nose, or that delivers a bolus ofoxygen upon detection of an inspiratory effort. This system does notmechanically support the work of breathing of the patient, and has notbeen proven to be effective in preventing moderate to severe forms ofOSA. FIG. 7 also describes another oxygen delivery therapy, high flowoxygen therapy (HFOT), in which more than 15 LPM of humidified oxygen isdelivered at a continuous flow rate to the user's nose. Because of thehigh flow required for HFOT, the system may be non-portable and theoxygen must be humidified.

Now referring to FIGS. 8-58, an embodiment of the subject invention isdescribed where a person receives mechanical ventilatory or airwaysupport by gas that is delivered to the nasal airways from gas deliverynozzles positioned below the nose, and in which the nose is free inhaledirectly from ambient air and exhale directly into ambient air. In FIGS.8-36, an embodiment of the invention is described in which the gasdelivery nozzles are positioned under the nose using a nose support thatphysically engages with the bridge of the nose. In FIGS. 37-58, anembodiment of the invention is described in which the gas deliverynozzles are positioned under the nose without any physical contact withthe bridge of the nose. In the various embodiments described wherein thegas delivery ports are positioned a distance away from the nostrils infree space, while the ports are a distance away from the nostrilentrance, a breathing sensor may be placed in closer proximity to theentrance to the nostril, or there is some other breathing sensor placedelsewhere. This may ensure that the gas delivery dynamics provide thepower and efficacy needed through proper geometry, but withoutsacrificing breathing detection and monitoring.

In FIGS. 8 and 9, a side view and front view respectively are shown of anasal interface 800 of an embodiment of the invention. A left cannula801 may have a left distal end 803 and a right cannula 900 may have aright distal end 901. As used herein, terms such as left, right, top,bottom and other directional references should be understood to beinterchangeable and are not meant as absolute determinations. Generally,directions are given relative to a user, such that a left cannula islocated on the user's left side. Similarly, reference to a left or rightnostril does not mean that the system cannot be reversed unlessindicated otherwise. The left distal end 803 and/or right distal end 901can optionally be connected with a coupler 907 beneath a nose 807. Thecoupler 805 can include a breath sensor (not shown). A skin pad 903 canbe included on the posterior or skin side of the coupler 805 to set therequired distance between the cannula tips 803, 901 and the skin, and toalign nozzles 809 at the cannula tips 803, 901 relative to the nostrilentrance and nostril foramen.

A head strap 811 may be connected to the cannula 801, coupler 805 orskin pad 903, and may be extended to the back of the head to secure theinterface 800 in place. The cannula 801, 900 may be routed bilaterallyfrom the nostrils to below the nostrils, then laterally and posteriorlyto the sides of the face, then inferiorly around the corners of themouth and ultimately to the front of the neck where the cannula areattached to a ventilation gas supply tube. Alternatively, the cannulacan be routed bilaterally from the nose to above and around the ears tothe front of the neck. The cannula can be preformed in one or more ofthese compound arcuate shapes to help position the cannula in the mostcomfortable and least obtrusive part of the patient's anatomy, and tosecure the device in place and resist shifting and movement. There maybe length adjustment features to adjust the distance between the twocannula nozzles, and cannula tip angle adjustment features to align theangle of the nozzles with the nostril entrance and foramen. Additionaldetails of these features will be described subsequently. Other shapes,adjustment features and fastening features are also included in theinvention which will also be described subsequently.

Embodiments of the present invention may have various benefits overstandard oxygen therapy nasal cannulae and masks. Existing systems mayhave limited therapeutic effects. For example, geometries in existingsystems may not be optimized and velocity flow dynamics of gas exitingcannula tips may be sub-optimal. Embodiments of the present inventionmay have improved efficiencies due to optimized jet pump geometries.Additionally, existing systems may be uncomfortable for a patient. Thevelocity of gas exiting existing cannulae, even though un-optimized, maybe extremely uncomfortable for a patient as the gas flow may beturbulent and irritating to the nasal mucosa. A gas profile inembodiments of the present invention may be more organized and/orlaminar when the gas enters the nose. Confidential experience withpatients indicates that patients with high liter flow oxygen areuncomfortable with their oxygen, but were comfortable with nasalinterfaces as described herein. Furthermore, if the cannula tips ofexisting systems are retracted to be placed outside the nose to improvethe geometry and flow profile, the cannula can no longer sense thepatient's breathing and the system may not be able to trigger.

As shown in the cross sectional view in FIG. 10, a tip 1005 of a nasalinterface 1001 may be reduced in diameter to create a nozzle 1003. Thedistal tip 1005 of the nozzle 1003 may be positioned proximally relativeto the entrance of a nostril foramen 1007 in the nasal septum 1009 so asto create a jet pump. The distal tip 1005 of the nozzle 1003 may be inproximity to the nostril rim and opening 1011 and nostril wall 1013. Thejet pump inlet may be defined by the rim of the nostrils, and the vacuumentrainment area of the jet pump 1015 may be proximal to and slightlywithin the entrance of the nostrils. The jet pump throat area may be theproximal section of the nostril foramen 1007. This jet pump geometry ofthe invention may facilitate entrainment of ambient air, such that thetotal gas being delivered into the patient may be of greater volume thanthe gas exiting the catheter alone, and with sufficient power due to thejet pump configuration, to penetrate airway resistances. Thisfacilitates more effective ventilation of the lung or airways. Theparameters of the invention are compared to the prior art therapies inTables 1 and 2 below.

TABLE 1 Comparison of Embodiments of the Invention with Prior ArtTherapies Lung Volume Augmentation Parameters INVENTION PRIOR ARTParameter Range Preferred (Adult*) OT HFOT CPAP Lung Volume Augmentation(%)     10-150%    15-65% 0%     0-25%     0-90% WOB reduction (%)    5-80%    10-50% 0%     0-25%     0-75% Lung Pressure increase (cwp) 1-30  3-20 0 0-6  3-25 Upper Airway pressure increase (cwp)  3-34  7-250-2  2-10  3-25 Lung Waveform S-R R no effect S-R S-R Entrained ambientair (%)     20-200%     50-100% 0 0 0 Gas exit speed out of catheter orpatient  25-300  50-200 10-30 40-60  5-10 interface (m/sec) EquipmentOutput flow rate, ave (LPM)  5-40 10-20 1-6 10-20 40-80 Tubing outerdiameter to patient (mm) 3-7 4-6 4-6 10-18 18-22 Equipment OutputPressure (psi) 10-60 20-40  5-40  5-20 0.1-0.5 Equipment Drive Pressure(psi) 10-60 20-40  5-40  5-20 ambient Equipment Operating Pressure (psi) 5-40 25-35  5-40  5-20 ambient Equipment Output Volume (ml){circumflexover ( )}  10-300  25-150  16-100 167-350 ml  0-500 Equipment OutputPulse Time (sec.) 0.100-1.000 0.200-0.700 0.25-1.0  Cons't Flow Cons'tFlow Therapy's source gas consumption 0.25-3.0  0.75-1.5  1-6 10-20 selfgenerating Equipment Output Synchronization (ms) variable depending onvariable depending on 0.1-0.2 Cons't Flow Cons't Flow comfort and needcomfort and need (25-500 ms delay) (75-250 ms delay) Equipment OutputWaveform S, D, A, Si, O R, D S, D Cons't Flow Cons't Flow NOTES:*Pediatric and neonatal: Pressure and volume values are 25-75% less(Ped) and 50-90% less (Neo). {circumflex over ( )}If constant continuousflow system, Output Volume = volume delivered during pt's inspiratoryphase Equipment: = ventilator for Invention and CPAP; = oxygen therapydelivery device for OT and HFOT OT = oxygen therapy; CPAP = continuouspositive airway pressure for NIV or OSA; HFOT = high flow oxygen therapyCPAP also includes BiPAP Square, Rounded, Decending, Ascending,Sinusoidal, Oscillating Cons't Flow = Constant Flow (not synchronized)

TABLE 2 Comparison of Embodiments of the Invention with Prior Art OSATherapies Sleep Apnea Therapy Parameters INVENTION PRIOR ART ParameterRange Preferred (Adult*) CPAP Airway Pressure (cwp) 0-30 5-25 1-25 LungPressure increase (cwp) 0-20 4-20 1-25 Upper Airway pressure increase(cwp) 3-30 7-20 1-25 Lung Waveform S-R R S-R Tubing outer diameter topatient (mm) 3-7  4-6  18-22  Entrained ambient air (%)    20-200%   50-100% 0 Gas exit speed out of patient interface (m/sec) 25-30050-200 5-10 Ventilator Output Pressure (psi) 5-40 25-35  0.1-0.5 Ventilator Output flow rate, ave (LPM) 5-40 10-20  40-60  VentilatorOperating Pressure (psi) 10-60  20-40  0.1-0.5  Ventilator Output Volumeper breath (ml){circumflex over ( )} 50-500 60-150 500-800  VentilatorOutput Pulse Time (sec.) 0.250-2.000  0.400-1.250  Contant FlowVentilator Output Synchronization SI, SR, SV, CVR SR Constant FlowVentilator Output Waveform S, D, A, Si, O R, A Constant Flow Breathingresistance (cmH2O @ 60 lpm)  0-3.0  0-2.0 4.0-6.5  NOTES: *Pediatric andneonatal: Pressure and volume values are 25-75% less (Ped) and 50-90%less (Neo). {circumflex over ( )}If constant continuous flow system,Output Volume = volume delivered during pt's inspiratory phase CPAP =continuous positive airway pressure; BiPAP = Bilevel Positive AirwayPressure SI = syncrhonized intermittent; SR = synchronized ramped; SV =synchronized variable; CVR = continuous variable ramped Square, Rounded,Decending, Ascending, Sinusoidal, Oscillating

FIG. 11 describes a version of a nasal interface 1105 in which a distaltip 1101 of a jet nozzle 1103 may be placed approximately coplanar tothe entrance to the nostrils. This placement of the nozzle may entrainmore ambient air compared to the nozzle being placed inside thenostrils, depending on other prevailing conditions, such as diameters,delivery pressures and alignment. Jet pump inlet and entrainment zone1107 is shown. FIG. 12 describes a version of a nasal interface 1205 inwhich a jet nozzle 1203 may be positioned such that a distal tip 1201 ofthe nozzle 1203 may penetrate the nostril foramen 1007 to create a jetpump inlet and entrainment zone 1207.

FIG. 13A shows a patient 1301 using an embodiment of the invention toprovide work of breathing support while ambulating. A nasal interface1303 may be minimally obtrusive compared to standard masks, so that thepatient can feel and act normal while receiving the therapy, see FIG. 2for details of an exemplary overall system. For example, the patient cantalk, swallow, eat or drink with the nasal interface and therapy. Thetubing required for the ventilation system may be very small compared tostandard ventilator tubing, which makes it much more realistic for thepatient to move around with the therapy, and to conceal the equipmentand tubing needed for the therapy. FIG. 13B shows the nasal interface1303 on the head of the patient 1301.

FIG. 14 illustrates an isometric view of a non-invasive open ventilation(NIOV) nasal interface assembly 1401. The assembly 1401 may include anasal interface 1403, and a ventilation gas attachment 1405 coupled tothe nasal interface 1403. Ventilation gas may be delivered from aventilator through a ventilator attachment 1427, gas delivery circuit1429 and the ventilation gas attachment 1405. A ventilation gas outlet1415 may be positioned at a distal end of the ventilation gas attachment1405. One or more nozzles 1417 may be located at a distal end of theventilation gas outlet 1415. Preferably, a distal end of the ventilationgas outlet may be positioned approximately 0″ to approximately 1.5″outside a nose. More preferably, the distal end of the ventilation gasoutlet may be positioned approximately 0.75″ to approximately 1.25″outside of a nose.

In addition to the gas delivery circuit 1429, a sensing tube 1431 may beconnected between the nasal interface 1403 and the ventilator attachment1427. The sensing tube 1431 may be a pressure sensing tube. The sensingtube 1431 and/or the gas delivery circuit 1429 may pass through a shell1433 of the nasal interface 1403. One or more sensors or sensing ports1435 may be located in various positions on the shell 1433. The one ormore sensors 1435 may be airway pressure sensing attachments or flowsensing attachments, but other types of sensors may be used on or nearthe nasal interface 1403. In certain embodiments, ports 1435 must be ina nostril cavity path to trigger the one or more sensors 1435.Embodiments of the present invention may also include one or moresensors that are carbon dioxide sampling ports. The carbon dioxidesampling ports may be attached to a sampling line on an external surfaceof the shell 1433.

Embodiments of the present invention may be adjustable or may come invarious sizes to accommodate different patient sizes. For example, theshell 1433 may come in various dimensions to accommodate various sizenoses. A ledge 1411 may be coupled to the shell 1433 for contacting anostril rim and positioning the nasal interface 1403. The shell 1433 maybe self-centering on the nasal bridge. An air knife deflector 1419 mayprevent an air knife effect from disturbing the eyes.

During testing, it was determined that the optimal performance wasachieved when the nozzles were aimed parallel to the bridge of the noseto align the jets of ventilation gas with the nares. The nozzles of theinterface may be aimed parallel to the mask 1433, such that by placingthe mask 1433 on the bridge of the nose, the nozzles 1417 may beparallel to the bridge of the nose. If there is some misalignment,performance may degrade. The jets preferably are kept within 10 degreesof being properly aligned with a nasal opening and an axis of the nares.

As such, when a patient moves their nose to the left or right (e.g. bymoving your jaw in an exaggerated manner), the nasal interface 1403 mayfollow the nose, ensuring that the nozzles remain aligned with thecenterline of the nose, and therefore the nostrils.

FIG. 15 is a close up rear view of the distal end of the nasal interface1403 of FIG. 14. FIG. 16 illustrates a close up front view of the nasalinterface 1403 of FIG. 14. FIG. 17 illustrates a close up top view ofthe nasal interface 1403 of FIG. 14.

FIG. 18 illustrates a bottom view of how the nasal interface 1403 ofFIG. 14 may communicate with a nasal airway 1801 of the patient. Thenasal airway 1801 is represented by the oval patterns. Gas deliverynozzles 1803 and nasal air pressure sensing locations 1805 are indicatedby the large and small circles, respectively. The nasal air pressuresensing ports may be protrusions to help achieve a positive location ofthe sensing ports in the breath path in the nares. The gas deliveryports may be positioned such that the gas delivery path has a clear pathto the nostril airway. There may be two or more sizes of masks, and oradjustment features in the mask, so that the sensing ports and gasdelivery zones are properly aligned with the nasal airway path. Theprevious figures describe that the sensing locations must be inproximity to the entrance of the nostril, either inside, coplanar to theentrance, or slightly outside but if outside no more than 5 mm away fromthe entrance, whereas the jet nozzle tips are located a distance fromthe entrance to the nostrils, for example 10-25 mm away. Thisconfiguration may allow the mask to take advantage of the jet pumpgeometry, while not sacrificing sensing accuracy, so that the ventilatoris in proper synchrony with the patient. Also, the gas flow profile maybecome more organized before entering the patient's nostril, rather thana turbulent jet entering the nostril, which would be quite uncomfortableand intolerant to the patient.

FIG. 19 shows a variation of the above embodiment in which gas deliveryports 1901 may be positioned and aligned below a nose 1903 by beingcoupled to a manifold 1905 that is coupled to the end of a nose bridgepiece 1907. The nose bridge piece 1907 may be coupled to a nose bridgesupport 1909. The nose bridge support 1909 may secure the system inplace. The nose bridge piece 1907 may be narrow providing for anaesthetically appealing design, but also may be functional in that thenose bridge piece 1907 precisely locates the gas delivery nozzles 1901.The gas delivery tubes 1911 may be coupled to the nose bridge support1909. Ventilation gas may be channeled to the gas delivery nozzles 1901through at least one channel 1913 in the nose bridge support 1909 and/ornose bridge piece 1907. A nasal air pressure sensing line 1915 may alsobe attached to the nose bridge support 1909. The nasal air pressuresensing line 1915 may communicate with a pressure sensing conduit 1917in the nose bridge support 1909 and/or the nose bridge piece 1907. Thenasal air pressure sensing line 1915 may terminate at or near themanifold 1905, typically closer to the nasal entrance than the nozzles.

The nose bridge support 1909 may be made of malleable material so thatit can be conformed ideally to the user's nose, and the bridge piece canbe adjustable to help align the nozzles correctly, or to adjust thestrength of the therapy by changing the distance of the nozzles to thenose. The support and bridge piece can be padded on the skin side tooptimize the comfort of the fit, and/or can include a pressure-sensitiveadhesive that helps secure it to the skin. The support can also possesshape memory properties such as nitinol, spring steel or athermoplastic, such that it compresses to lightly pinch the nose. Thesupport and bridge piece can also be used to prevent distension of thenostrils when the nasal cavity is pressurized by the delivery of theventilation gas. The gas delivery and nasal airway pressure sensinglines can be pre-formed into a shape to keep the tubing away from theuser's eyes. The tubing is shown as typically be routed above and aroundthe ears, however it can be routed around the corners of the mouth tothe front of the neck, in which case a strap would attach the mask tothe face. As in other embodiments described herein, the gas deliverychannel and nasal airway pressure sensing channel can be separate lumensin the same tubing, or can be separate tubes.

FIG. 20 describes a similar version to FIG. 19 in which a nose bridgesupport 2001 and a nose bridge piece 2003 are more substantial, whichcould be more useful in more critical applications in which aestheticsare less important, for example emergency or critical care.

FIGS. 21-24 illustrate various different configurations of the aboveelements. For example, FIG. 21 shows a gas delivery circuit 2101 and asensing tube 2103 external to a nose bridge support 2105 and a nosebridge piece 2107. FIG. 22 shows a more substantial connection between anose bridge piece 2201 and a manifold 2203, such that they are a unifiedpiece. FIG. 23 shows a similar configuration to FIG. 22 except amanifold 2301 is separate from the nose bridge piece 2303. FIG. 24 showsa configuration with a nose bridge piece 2401 surrounding nozzles 2403.

FIGS. 25-34 describe an embodiment where a nose bridge piece 2501 islocated to one side of a nose 2503, rather than along the midline of thenose 2503. A gas delivery circuit 2505 may supply ventilation gas to anose bridge support 2507. A sensing tube 2509 may also be coupled to thenose bridge support 2507. The nose bridge piece 2501 may be coupled to amanifold 2511 with one or more nozzles 2513. In FIG. 26, a gas deliverycircuit 2601 and nasal airway pressure sensing line 2603 may attach to amanifold 2605 to help secure the system in place. FIG. 27 shows a gasdelivery nozzle within a manifold 2701, so that the manifold can diffuseand dampen the noise generated by the gas exiting the nozzles. Ports2703 may allow passage of ventilation gas. FIG. 28 shows a gas deliveryconduit 2801 routed unilaterally to one side of the face to free theopposite side from any objects. A skin cushion 2803 may hold a nosebridge support 2805 on a nose 2807. A manifold 2809 may be coupled to aside nose bridge piece 2811. FIG. 29 shows an embodiment similar to FIG.28 where a nose bridge support 2901 is held in place by or coupled toglasses 2903. FIG. 30 shows a unilateral configuration with a sensingtube 3001 following the path of a gas delivery circuit 3003 and held inplace with a skin cushion 3005 on a nose 3007. Tubes may be combined ina multi-lumen system or may remain separate. Tubes may be held in placewith bendable wires. Tubing may be integrated into a strap. FIG. 31shows a sensing tube 3101 on an opposite side of a face from a gasdelivery circuit 3103. FIG. 32 shows a sound muffler 3301 incorporatedinto a manifold 3303. Jet nozzles may be located below within or belowthe manifold 3303. FIG. 33 is a close up anterior view of the embodimentof FIG. 32. A nose support piece 3401 may have a nose coupler 3403 andan inlet 3405 for gas from a gas delivery circuit (not shown). An arm3407 may couple the nose support piece 3401 to the manifold 3303. FIG.34 is a close up posterior view of the embodiment of FIG. 32.

FIG. 35 shows an alternative embodiment of positioning gas deliverynozzles 3601 below a nose 3603. A bracket 3605 may extend from the nose3603 to one or both ears 3607. At an anterior end of the bracket 3605, aducting system 3609 may be attached, which may include the nasal airwaypressure sensing limbs 3611 that terminate close to and under the nose3603. The anterior end of the bracket 3605 may also include a gasdelivery limb 3613 that may include a gas delivery manifold 3615 towhich the gas delivery nozzles 3601 may be mounted. The system mayinclude adjustment features to align the sending and delivery nozzlescorrectly.

FIG. 36 shows gas delivery tubing 3701 and a nose support 3703. The nosesupport 3703 may hold the nasal interface in place on the face. Abracket 3705 may extend from the nose support 3703 to a gas deliverymanifold 3707. The bracket 3705 can be flexible or adjustable so thatthe user can adjust as desired.

FIGS. 37-53 describe certain embodiments of the invention in which thegas delivery nozzles are positioned under the nose without the use ofbrackets or nose supports, but with the use of tubing or head straps.

FIG. 37 describes a front view of an embodiment of a distal end of apatient interface. Gas delivery jet nozzles 3801 may be located at anend of a cannula 3803, wherein the cannula 3803 and/or nozzles 3801 areattached to a head fastener 3805 via one or more cannula connectors3807. In this embodiment, the patient's nostrils serve the role of theouter tube and jet pump inlet, throat and diffuser. Optionally, outertubes, which are separate components, can be independently be placed inthe nose, and the interface shown in FIG. 37 can then be fastened to theface so that the nozzles are aligned and positioned correctly with theouter tubes. In FIG. 37, left and right cannula may be connectedtogether by an extension of the fastener or by a coupler 3809. Thecoupler 3809 can include length and angle adjustment features. The jetpump nozzles 3801 may create a jet pump inlet and entrainment area 3811.A sensor 3813 may be coupled to a controller (not shown) via a sensorwire 3815.

FIG. 38 shows an embodiment where a left and right cannula 3901 may beinterconnected with an air flow path 3903, such as a manifold 3905, andthe portion of the nasal interface that includes the distal tip jetnozzle 3801 can extend upward from the manifold 3905.

FIG. 39 shows an alternative embodiment in which the jet nozzles 4003 ata distal end of a cannula 4001 may be apertures in a superior wall ofthe cannula 4001, and wherein the cannula 4001 is curved laterally toone or both sides of the nose. The low profile nozzles 4003 may allowthe cannula 4001 extending away from the nozzles 4003 to be locatedclose to the nose and away from the mouth, to create an unobtrusivedesign. As shown in FIG. 39, the gas flow paths of the left and rightcannula may not connect in the manifold 3905 but end at the nozzles4003. As the gas enters the nozzle 4003 from the cannula gas flow path3903, the gas flow path 3903 may be curved to help create a uniform andconsistent gas flow profile in the nozzle. Optionally, the gas flowpaths can connect in the manifold 3905.

The embodiments shown in FIGS. 37-39 may or may not include outerconcentric tubes around the outside of the nozzle. These embodiments canbe combined with a length adjustment coupler in between the nozzles orouter tubes, angle swivel connections between the nozzles and manifoldor between the outer tubes and the coupler.

FIG. 40 shows a side view of an embodiment of the invention in which thenasal interface 4101 includes a locating device 4103 to align andposition a tip 4105 of the nasal interface 4101 correctly, in relationto the nostril foramen. The locating device 4103 can be a soft butsemi-rigid arm that impinges on the nostril wall or nostril septum. Forexample, the locating device 4103 can lightly pinch the nostril septumby two arms that press inward on the left and right wall of the nostrilseptum. There can be one or more arms for each nostril, or just one armfor both nostrils. The arms can contact the posterior, anterior, lateralor medial wall of the nostril, or optionally can contact an outside wallof the nostril. The locating device 4103 may be attached to the gasdelivery circuit 4107 such that the distal tip and gas exit port of thenozzle is directed as desired toward the nostril foramen. FIG. 41 showsa front view of this embodiment with a connector 4201 between oppositesides of the gas delivery circuit 4107.

FIG. 42 shows a cross sectional schematic of the embodiment shown inFIGS. 40 and 41. A jet pump nozzle 4301 may be positioned within thenasal septum 4303, nostril wall 4305, nostril foramen 4307, nostril rimand opening 4309, and/or jet pump throat 4313 to create a jet pump inletand entrainment zone 4311.

FIG. 43 shows a cross sectional schematic view of an embodiment of anasal interface 4405 that may include an adjustment feature 4401 coupledto an adjustment arm 4407 that is used to adjust the position of anozzle 4403 relative to the nostril. Primarily, the depth of insertionof the nozzle 4403 into the nose may be adjusted by this adjustmentfeature 4401; however, the alignment and centering of the nozzle 4403can also be adjusted, relative to the nostril opening and nostrilforamen.

FIG. 44 shows a cross sectional front view of a right nostril and analternate embodiment of a nasal interface 4501, in which an attachmentand positioning pad 4503 may be included with the system. The nasalinterface 4501 may be attachable to the attachment and positioning pad4503, and the attachment and positioning pad 4503 may also include anextension or locating tab 4505 in the superior direction configured anddimensioned for it to be inserted slightly into the nostril and placedagainst a posterior wall of the nostril. The locating tab 4505 maylocate the attachment and positioning pad 4503 in a known orientationand location, and a cannula (not shown) that may be attached to theattachment and positioning pad 4503, and nozzle 4507, may be, as aresult, positioned, oriented, and angled optimally toward the nostrilopening and nostril foramen. The attachment and positioning pad 4503 mayalso be used to position the distance of the cannula tip relative to thenostril opening to the optimal distance. The attachment of the cannulato the attachment and positioning pad 4503 can be a removable andadjustable attachment, so that the cannula position can be adjusted tomeet the needs and goals of the therapy, and to adjust the fit to matchthe anatomy of each individual.

FIGS. 45-59 describe a version of the above embodiment in which the gasdelivery nozzles are integral to a manifold that is positioned under thenose without the aid of nose supports or brackets.

In FIG. 45, a manifold 4601 with anatomically matching curves isdescribed. Gas delivery nozzles 4603 may be positioned on asuperior-posterior side of the manifold 4601, so that gas delivery isaligned with the nostrils. Gas delivery tubing 4605 and nasal airwaypressure sensing tubing 4607 may attach to lateral ends of the manifold4601, and the tubing 4605, 4607 may be used to secure the manifold 4601under the nose. As in other embodiments described herein, the gasdelivery channel 4605 and nasal airway pressure sensing tube 4607 can beseparate lumens in the same tubing, or can be separate tubes. Sensors4609 may be located on a superior-anterior side of the manifold 4601 orany other appropriate location. FIG. 46 is a close up side-front view ofthe manifold 4601 described in FIG. 45, showing the gas delivery nozzles4603 with gas delivery routing 4701, and nasal airway pressure sensingports 4609 with pressure sensing lumens 4703. FIG. 46 is a top view ofthe manifold 4601 shown in FIG. 46.

FIG. 47 describes an embodiment in which a sound baffle 5001 is providedabove gas delivery nozzles 5003 on a manifold 5005, so that the soundgenerated by the gas exiting the nozzles 5003 is muted. FIGS. 48 and 49describe rear and front views, respectively, of the manifold shown inFIG. 47. The baffles can also be used as flow organizers to adjust theflow velocity profile and dynamics as necessary. For example, thebaffles can take the incoming velocity profile and shape it to a moreuniform velocity profile on the outlet side, so that when the gas andentrained air enter the nose of the user, it feels more comfortable yetstill has the power to penetrate the respiratory system. The soundbaffles can also be used as cushions to impinge on the nostril in whichcase the baffles are comprised of a soft material.

FIG. 50A describes an embodiment in which a manifold 5301 includes gasdelivery nozzles 5303 as well as entrainment apertures 5305. FIG. 50Bdescribes an anterior view of this embodiment.

FIG. 51A shows describes an embodiment in which a manifold 5401 includesgas delivery nozzles 5403 as well as entrainment ports 5405. FIG. 51Bdescribes an anterior view of this embodiment.

FIG. 52 shows an embodiment in which a manifold 5501 includes gasdelivery nozzles 5503 recessed in the manifold 5501 to help dampen thesound that is generated and to position the manifold 5501 closer to thenose to reduce the profile of the nasal interface. An opening 5505 mayallow passage of ventilation gas.

FIG. 53 shows an alternative embodiment of FIG. 53 with a singleaperture 5607.

FIG. 54 shows an embodiment in which a bracket 5701 worn on the user'sface may position nasal airway pressure sensing ports 5703 below thenose and gas delivery nozzles 5705 below the nose. Gas delivery tubing5707 and pressure sensing tubing 5709 can be routed around the cornersof the mouth to the front of the neck or can be routed to above andaround the ears.

FIG. 55 describes a top view of a manifold 5801 of a nasal interfacethat is positioned under the nose, and shows gas delivery nozzles 5803and nasal airway pressure sensing ports 5805.

FIG. 56 describes a nasal interface in which a manifold 5901 ispositioned under the nose using a head set 5903 similar to a hands freemicrophone. A gas delivery channel may be integrated into a bracket 5905extending from above the ear to the manifold 5901 under the nose. Thebracket 5905 may be attached and secured to the head using a head bandor head brace 5907. The connection of the bracket 5905 to the head brace5907 may be disconnectable or a may be a swivel. For example, if theuser wants to sneeze or blow their nose, or discontinue or pausetherapy, the bracket 5905 may be swiveled upward, which can shut off thegas flow to the manifold 5901. FIG. 57 shows a posterior view of theembodiment of FIG. 56 off of the user's head. FIG. 58 shows analternative to the embodiment of FIG. 56.

The nasal interface distal end designs shown in foregoing features mayinclude features and components that can be mixed in every possiblecombination to meet the needs of the particular clinical application,and to achieve a design that maximizes user ergonomics, and to achievedesired performance. The interface cannula can be routed to both sidesof the face, or to one side of the face. The cannula can be routed overthe ears, or up the center of the face between the eyes, or around thecorners of the mouth to the front or back of the neck. The strap orfastener used to fasten the interface to the head can be routed to theback of the head above the ears, or can be fastened around the neck. Theinterface can include length adjustment features to set the distancebetween the two nozzles, or angle adjustment pivot or swivel joints toset the angle between the nozzles or the angle in the sagittal plane inorder to align the nozzles with the nostril foramen. The interface candeliver gas in one nostril or both nostrils. Other routes of entry ofthe ventilation gas into the patient's airway are also included in theinvention, as will be described, with requisite modifications to makethe configuration compatible with outer entry points.

FIGS. 59-78 describe an embodiment of the invention in which gas may bedelivered to the nasal airway using a nasal interface that includes amanifold. The manifold may (a) engage with the nostrils, and/or (b)extend bi-laterally from the nostrils to the sides of the nose, and/or(c) include gas delivery nozzles placed in the manifold, typically at alateral end of the manifold.

FIG. 59 shows an exemplary embodiment where a manifold 6301 may becurved and configured to be placed under the nose of the user, and whichmay extend bilaterally from the midline of the face to the sides of thenose. FIG. 60 shows a front-bottom view of the manifold 6301 of FIG. 59.FIG. 61A shows a top-front-side view of the manifold 6301 of FIG. 59.FIG. 61B shows a front-side view of the manifold of FIG. 59. A soundreducing aperture or slit 6621 may be provided. FIG. 62A shows a rearview of the manifold 6301 of FIG. 59. FIG. 62B shows a sectional view ofthe manifold 6301 of FIG. 62A along a mid-line A-A showing a gas flowpath 6601. FIG. 63A shows a rear-side view of the manifold 6301 of FIG.59. FIG. 63B shows a sectional view of the manifold 6301 of FIG. 63Aalong a line B-B showing an end view of a gas delivery nozzle.

The manifold 6301 may include a gas flow path 6601 inside the manifold6301 and a gas delivery tube attachment 6302. The gas flow path 6601 mayterminate at a distal end at gas flow openings 6603 at a superior sideof the manifold 6301 positioned just lateral to a midline 6303 of themanifold 6301 on both sides of the midline 6303, and terminate atproximal ends 6605 spontaneous breathing and entrainment at twoapertures on the inferior-anterior side of the manifold 6301. Typically,there may be pneumatically separate left and right gas flow paths 6601;however, the two gas flow paths can alternatively be pneumaticallyjoined together with a channel. A channel may be useful in providingbalanced flow delivery to both nostrils in the event one nostril iscongested. The ventilation system may include an alarm that may detecthigh levels of pressure in the manifold, for example, if one of theapertures is occluded. The manifold 6301 may be typically shaped in acompound arcuate shape to match the contours of the face under and tothe side of the nose. The manifold 6301 may typically curve bilaterallyand posteriorly. It can in addition curve superiorly or inferiorly as itis curving laterally and posteriorly. The overall manifold assembly canbe a bilateral assembly meaning the gas delivery is attached to both theleft and right side, or it can be unilateral meaning that the gasdelivery is attached to only one side. The later configuration may beuseful for side sleeping or to reduce the obtrusiveness on one side ofthe face. The manifold cross sectional geometry is typically variable,and can be generally round or semi-round, or can be D-shaped or oval inorder to optimize performance and ergonomics. Flatter cross sectionalgeometries that do not protrude far from the user's skin may bepreferred ergonomically. The internal structure of the manifold may bedevoid of corners and abrupt bends and angles to facilitate efficientgas flow fluid dynamics and sound generation. The manifold may betypically made of a semi-rigid material, either a thermoplastic orelastomeric material, typically of 30-90 Shore A hardness. The manifoldcan also be constructed to be malleable or moldable by the user for theuser to make minor adjustments to allow the manifold to fit ideally tothat individual. The overall assembly can be disassemble-able, so theuser can take the assembly apart for cleaning, or to assemble correctsizes of the different parts together to customize the fit. The manifoldand cushions, if included, may typically be translucent, but also can betransparent or opaque. Humidification can be added to the gas deliverycircuit, either by active heated humidification or by aerosolizingmoisture particles into the gas delivery system, typically into or fromthe manifold or a heat moisture exchange (HME) or combinations of theabove. To prevent rainout from occurring in the manifold, the manifoldmay have a drainage line to scavenge any moisture that is collecting.

Two tubular extensions 6305 may be coupled with and extend superiorlyfrom the distal end gas flow openings 6603. The tubular extensions 6305may be configured to impinge with the nostrils and optionally sealagainst the nostrils by engaging the rim of the nostril. The extensions6305 are typically soft and compliant to allow for comfortable contactwith the nostril and, if a seal is intended, compress against thenostril in a comfortable manner. The extensions 6305 may be fit on stems6311. The gas flow path 6601 in the manifold 6301 may be dimensionedsuch that the patient can breathe freely through the gas flow pathwithout feeling restricted. The gas flow path 6601 may be curved anddevoid of abrupt angles and corners in order to channel the gas with aslittle resistance and disturbance as possible. Gas delivery jet nozzles6607 that may deliver the supplemental ventilation gas into the manifold6301 may be positioned at the lateral proximal ends of the manifold6301. Gas exiting the nozzles 6607 may entrain ambient air from thenearby manifold apertures 6605. The gas delivery jet nozzles can bepositioned in the manifold near the base of the nasal cushions, orinside the nasal cushions, or can be positioned in the manifold at adistance proximal to the nasal cushions. The nozzles can be positionednear the lateral ends of the manifold in which case the manifoldinternal geometry is devoid of abrupt angles and corners, so that thegas being delivered by the nozzles flows in an organized flow profilewith minimal turbulence. The nozzle exit vector or directional alignmentpreferably is aligned with the average centerline arc of the manifoldinternal geometry. This may be important to make the system moreefficient and to produce less sound. Typically the nozzle may becentered with respect to the manifold internal geometry at the locationof the nozzle; however, it can also be off-center, for example, insituations in which minimal sound generation is desired. The manifoldinternal geometry can be round in cross section or can be non-round,such as D-shaped, oval, or elliptical, in order to optimize both flowdynamics, sound and ergonomics. The jet nozzle tip inner diameter canrange from approximately 0.010″ to approximately 0.080″ in diameter oreffective diameter, and may be preferably approximately0.020″-approximately 0.060″ in diameter or effective diameter. Otherdimensions are possible depending on certain uses. The position of thenozzle relative to the manifold and the apertures can be adjustable suchthat the adjustment can change the level of ventilatory support providedif so desired. Typically the jet ports are positioned bilaterally;however a single jet port is also contemplated.

The inspired gas may be a combination of (1) supplemental ventilationgas being delivered from the ventilator through the nozzles, (2)entrained air drawn through the apertures by the ventilation gas exitingthe nozzles, and (3) air drawn through the apertures from the user's ownspontaneous breathing effort. Exhaled gas may be exhaled entirelythrough the apertures 6605.

In addition, the pressure inside the manifold 6301 may be measured by apressure tap 6611, and this pressure may be continuously measured by atransducer in the ventilator by a conduit connecting the pressure tap6611 to the transducer. The measured pressure inside the manifold 6301may be used to detect the phases of the breathing cycle, and to measurethe delivered ventilation pressure. Ideally, the pressure tap 6611 mayterminate at a point in the manifold gas flow path 6601 that has as fewartifacts as possible, typically as close to the distal end of the gasflow path 6601 in the manifold 6301. There may be multiple pressure tapsin the manifold 6301 to measure pressure in multiple locations in themanifold 6301, for example to determine flow by measuring the pressuredifference between two pressure tap locations, or for example to measureat one location during inspiratory phase and a second location duringexpiratory phase, or for example one pressure tap to be used to detectspontaneous breathing signals and one pressure tap to be used to measurethe ventilation pressure being delivered.

The supplemental ventilation gas from the ventilator may be delivered tothe manifold 6301 from the ventilator via tubing 6307, which may becoupled to proximal ends 6309 of the manifold 6301. This tubing 6307 mayinclude both the ventilator gas delivery channel and the pressure tapconduit. The tubing 6307 may typically extend around the ear to securethe nasal interface to the patient, or may be routed in other positionson the user's face, for example, around the corners of the mouth to thefront of the neck, in which case a strap may be included to strap themanifold to the face and head.

For the purpose of these descriptions, the terms tubular extensions,nasal pillows, nasal cushions may be used interchangeably to describethe tubular bodies that impinge on the nose. These bodies may impinge onthe rim of the nostril, seal on the rim of the nostril, seal inside thenostril, impinge on the tissue underneath the nose, or variouscombinations of the above. The tubular extensions 6305 may typicallyinclude convolutions in the shape to allow the extension to flex inmultiple planes, and to compresses along a centerline axis, to conformto the user's nose. The extensions 6305 can be permanently affixed tothe manifold 6301 or can be removably attached. The extensions 6305 ornasal cushions are described in more detail as follows. The nasalcushions can be positioned on the superior surface of the manifold, orthe superior-posterior surface. The cushions can seal against thenostril rim or other part of the nostril so that there is notinadvertent leakage between the cushion and nose and so that themajority of the breathing gas flows through the cushion. However, thisseal does not need to be leak free, and in some embodiments the may be adesired gas flow between the cushion and the nostril. The cushions canbe attached to the manifold with a flex joint or corrugation in order toallow the cushions to flex, bend, or angulate under slight pressure sothat they self-align with the nostril openings. The cushions can alsocompress inward toward the manifold so that the contact force at thecontact point between the cushion and the nostril is dampened andabsorbed. These features may make the cushion a flexible seal orflexible quasi-seal and may make the assembly more forgiving to matewith different facial structures and inadvertent movement of theassembly while being worn. The cushions are typically a compliantmaterial such as silicone or elastomeric or thermoplastic material ofShore 10-60A, but other materials may be used. The cushions can also beremovably attachable from the manifold and available in different sizesso that the user can select a size that matches their anatomy.

The gas flow path 6601 in the manifold 6301 can be defined by twoseparate paths; a left path and right path that are separated by aseptum 6609 at the midline 6303 of the manifold 6301. Alternatively theleft path and right path can be interconnected at the midline of themanifold 6301, for example, to balance out the gas flow if one side ofthe nasal airway is more resistive than the other. Materials anddimensions of this embodiment are further explained in Table 3. Inaddition, FIG. 61B shows a sound reducing aperture 6621 communicatingwith the gas flow path 6601 is shown, which allows for an exit pathwayfor gas venting to reduce gas-gas shearing and resultant sound

The apertures 6605 may address two functions: (1) the apertures mayallow ambient air to be entrained by the jet ports, and (2) theapertures may allow for the patient to spontaneously breathe through themanifold. The aperture can be a single aperture, or multiple apertures.The entrainment aperture can be the different from the spontaneousbreathing aperture, or the apertures can be separate. The spontaneousbreathing apertures can be roughly or substantially in-line with the gasflow openings of the nasal cushion or manifold, or can be on thesuperior surface of the manifold, the inferior surface, the anteriorsurface, or a combination of these surfaces. In general, the spontaneousbreathing apertures are preferably placed so that the exhaled gas fromthe patient is directed in a natural vector or direction. Theentrainment aperture is preferably near the jet exit ports however canbe placed in other locations on the manifold as well. The entrainmentapertures can be positioned near the lateral proximal ends of themanifold and can be on the superior, anterior, inferior surfaces of themanifold or combinations thereof. The apertures can be variablyadjusting for example can be adjusted between fully open and fullyclosed. The adjustment can help adjust and control the level ofventilatory support to the desired level that the overall system isintended to provide for the prevailing situation. The adjustment can bemanual, but is preferably automatic with the use of valves, for examplea valve that is controlled by a pressure signal delivered from theventilator though a small bore conduit to the valve. The level ofsupport can range from partial support to full ventilator support.

Sound generated by the jet nozzles and resultant entrainment, gas-gasshearing, and gas-surface shearing, can be abated by shrouding thenozzles, by covering the apertures with a sound filter media, bycovering the apertures with low resistance mufflers, by treating andcontouring the surfaces, or by optimizing the flow path geometry topermit a highly organized gas flow profile. The nozzle exit port canalso be rounded to reduce noise generation. The inner wall of themanifold can be treated or textured to create additional sound barrier.The manifold material itself can be sound retardant to absorb andreflect sound, so that sound generated by the jet nozzles does notescape the manifold, for example, but not limited to, by using a porousbut antimicrobial material. The inner manifold surface can also includea helical rib or ribs or helical groove or grooves to help organize thegas flow profile into a dynamic that produces less sound as a functionof total volumetric flow rate.

The breathing of the user may be sensed by one or more respirationsensors. The sensors may be positioned inside the manifold 6301, or onthe surface of the manifold 6301. The sensors may be positioned in alocation that is minimally affected by artifacts caused by the jet, suchas a vacuum signal. The sensor may typically be a pressure sensing portand sensing lumen that extends back to the ventilator and is incommunication with the ventilator control system. However, the sensorcan be other types as well, such as thermal, sound, vibration, gascomposition, humidity, and force, or any combination thereof. The sensorcan be used to measure breathing pressures, but can also be used tomeasure breathing gas flows, or other breath-related parameters, such assound or gas composition. There may be a combination of breath sensorsinside the manifold and a breath sensor on the outside of the manifold.The sensing element can be integral to the manifold, or in theventilator. There may be two breath sensors, one for each nostril, or asingle breath sensor. There may be multiple breath sensors for anostril, for example an inspiratory breath sensor, and an expiratorybreath sensor. The breath sensors can also be used to measure gas flowand gas volume, for example inspired and expired flow rate and inspiredand expired tidal volume, of both the ventilator delivered gas and thespontaneously breathed gas. In addition to breath sensing, the apparatusmay also include gas composition sensors, such as end-tidal CO2 sensors,and oxygen sensors. CO2 is a useful clinical parameter to measure andrespond to, and can also be used as an additional breath detector, apneadetector, leak detector, and interface fitting detector (a certaincharacteristic CO2 signal may indicate proper or improper fitting andplacement of the interface). Oxygen sensing may be a useful parameter tomeasure and can be used to determine the FIO2 being delivered by thesystem to the patient and therefore can be used as a measured parameterand to make ventilator adjustments to achieve the desired FIO2.

Unfortunately, without the embodiments described above, the nasalinterfaces may generate an undesirable amount of noise because of thejet pump principle. Jet pumps are known to create noise from the gasvelocity exiting the jet nozzle, and the surrounding air being entrainedby the jet. In some applications of the invention, such as when the useris in public, or desires quite surroundings, or when being used duringsleep, it may be desired to have as little sound as possible. Placingthe jet inside an outer tube or manifold may help reduce the noise ofthe jet, for example from 25-35 db to 15-25 db. There are, however,additional ways to further reduce the noise generated by the nasalinterfaces of this invention, as shown in FIGS. 64A-65.

FIG. 64A shows a cross sectional schematic view of an embodiment forfurther reducing noise. One half of the nasal interface is shown, forexample, the left side or the right side. A gas delivery nozzle 6801 isshown positioned in parallel with a breathing aperture 6803, rather thancoaxial. For purposes of this disclosure, parallel refers to gas flowdirection. As such, the parallel position of FIG. 64A refers to theparallel flow of the ventilation gas delivered from the nozzle 6801 andthe flow of entrained ambient air through the breathing aperture 6803.This configuration may allow the device to accomplish three importantthings. First, it allows the nasal interface to be as small as possiblebecause the jet nozzle is not in the way of the spontaneous breathingpath. If the jet nozzle is in the spontaneous breathing path, the areaaround the jet nozzle likely must be bigger to compensate for the nozzleso that the flow path is not made too resistive. Second, the parallelaperture may allow the device to channel the gas flow away from themouth. Third, locating the aperture parallel to the nozzle may reducethe sound created by the nozzle 6801. An outer tube 6805 can be a nasalcushion or can be a manifold. The outer tube 6805 in the schematic isshown straight, but it could be straight or curved.

In FIG. 64B, a secondary gas flow aperture 6807 is shown. This secondaryaperture 6807 may allow for a second gas exit pathway during exhalationor when flow is traveling in both directions in the tube or manifold.

FIG. 64C shows an alternative secondary gas flow aperture 6809 with aninner tube 6811, in which the gas pathway is co-axial to the primary gasflow pathway. This embodiment is especially useful when the invention isused to delivery gas continuously to the patient, or when gas is beingdelivered during exhalation for example to create PEEP. In thesesituations, gas can be flowing in the manifold or outer tube in bothdirections simultaneously, in the inspired direction and the exhaleddirection, which increases the sound generated by the jet pump due tomixing. The secondary gas path may allow a significant amount of gasmoving in the exhaled direction to travel through the secondary pathwhich can reduce the noise considerably, for example from 30 db at 1meter to 15 db at 1 meter. The secondary gas flow path can be a slit, apattern of holes, or a channel. In addition to the embodiments shown, alow profile muffler can shroud portions of the manifold, as describedearlier.

FIG. 64D shows an embodiment with a filter 6813 at an aperture 6815, andoptionally inside the outer tube 6805 or manifold. A portion of theexhaled airflow may flow through the filter 6813 that may collect someof the moisture in the exhaled air. The collected moisture may beentrained with the jet when the jet nozzle is delivering air in theinspired direction. The configuration, therefore, may help recycle thehumidity for the patient to help ensure that the patient's airwayremains moist. The filter 6813 can also be used as a sound reducingmaterial, in which case the filter 6813 may cover the entire aperture,and may be less resistive than a humidity collecting filter. Inaddition, the filter 6813 can be used as a particulate filter, toprevent entrainment from introducing environmental dust and particulateinto the manifold and airways of the user. A fluted entrance 6817 of thebreathing/entrainment aperture may also be used, which may furtherreduce the noise generated by the nasal interface. The flute dimensionsmay help reduce the sound generated by entrained air by creating a lowfriction boundary layer. In addition, a surface at the aperture may bedimpled to further create a low friction boundary layer to reduce sound.

FIG. 65 describes an alternative embodiment of the invention in which anozzle 6901 may be angulated with respect to the axial centerline of anouter tube 6903 or manifold. In this case, the entrainment/breathingaperture 6905 may be co-axial with the jet nozzle 6901, rather than inparallel; however, it could also be in parallel or both. Angulating thenozzle 6901 into the wall of the outer tube or manifold may reduce thesound generated by the jet pump at a greater ratio than the loss ofentrainment performance. For example, a 30-degree angle may reducedownstream pressure creation by approximately 10-25%, but may reducesound generated by the system by approximately 25-75%, which is apreferred tradeoff in many situations.

FIGS. 66-68 describe versions of the embodiment described in FIG. 59.

FIG. 66 describes an embodiment in which a manifoldentrainment/breathing aperture 7001 may be located at a lateral end of amanifold 7003. A jet nozzle 7005 may be located lateral to the aperture7001. The jet nozzle 7005 may or may not be located within an outer tube7007. The jet nozzle 7005 may receive ventilation gas from a ventilatorvia a gas delivery circuit 7009. The manifold 7003 may interface withthe patient's nostrils using soft nasal pillows 7011. The manifold 7003may be split into left and right sides connected by a rigid, semi-rigidor flexible member 7013. One or more sensing lumens 7015 may measure thepatient's breathing. The one or more sensing lumens 7015 may be insidethe nasal pillows to improve signals.

FIG. 67 shows an embodiment in which a manifold 7101 may include a leftcurved cannula 7103 and a right curved cannula 7105. The cannula 7103,7105 can be connected to each other with an adjustable inter-connector7107, which can allow for spacing adjustment between the two cannulaeand allow pivoting or swiveling of the distal ends of the cannula tohelp align the cushions at the distal end of the cannula with the user'snostril. Nozzles 7109 may be open to ambient. FIG. 68 shows a posteriorview of the manifold 7101 of FIG. 67 with nasal pillows 7201. FIG. 69shows an anterior view of the manifold 7101 of FIG. 67.

FIG. 70 shows an embodiment in which a manifold 7401 may be shorter inleft to right length to reduce the size and profile of the nasalinterface. Nozzles 7403 are positioned laterally to the nose and nasalpillows 7405 engage the nostrils. FIG. 71 shows a posterior view of themanifold 7401 of FIG. 70. FIG. 72 shows an anterior view of the manifold7401 of FIG. 72.

FIG. 73 shows an embodiment in which a manifold 7701 has at least oneflattened section 7703 on a posterior side of the manifold 7701 so thatthe manifold 7701 lays flat against the surface of the skin to helpstabilize the manifold 7701 in place on the user. In addition, gas flowopenings 7705 at a superior side of the manifold 7701 may not includetubular extensions. In this embodiment, the gas flow openings 7705 maycommunicate with or impinge directly on the nostrils. FIG. 74 shows aposterior view of the manifold 7701 of FIG. 73. FIG. 75 shows ananterior view of the manifold 7701 of FIG. 73 with a jet nozzle 7731,gas delivery tube attachment 7733 and breathing aperture 7735.

FIG. 76 shows an embodiment in which a manifold 8001 is narrower in thetop to bottom dimension to space the manifold 8001 away from the mouthas much as possible. FIG. 77 shows a posterior view of the manifold 8001of FIG. 76. FIG. 78 shows an anterior view of the manifold 8001 of FIG.76.

FIG. 79 shows an embodiment including a manifold 8301, tubularextensions 8303 on the superior side of the manifold 8301 to impingewith the nostrils, and entrainment/breathing ports 8305 on the inferiorside of the manifold 8301 in alignment with the nostrils and tubularextensions. The entrainment/breathing ports 8305 can also be located onthe anterior side, or anterior-inferior side of the manifold 8301. Gasdelivery nozzles 8501, as shown in FIG. 81, may be positioned somewherebelow the tubular extensions inside the manifold. FIG. 80 shows ananterior view of the manifold 8301 of FIG. 79. FIG. 81 shows a crosssection through line A-A of the manifold 8301 of FIG. 80.

FIGS. 82-99 describe another embodiment of the invention in which gasfrom gas delivery jet nozzles is directed to the nostrils through anouter tube, such that the combination of the nozzle and outer tubedefine a jet pump configuration.

FIG. 82 shows an embodiment in which two tubes 8601, 8603 impinge withthe nostrils at their distal ends 8605, 8607 and curve laterally andinferiorly away from the nostrils. Gas delivery nozzles may bepositioned so that the nozzle is at, near or inside the proximal openingin the tubes. The nozzles can enter the tubes at the proximal opening,as shown, or can enter the tubes through the lateral wall of the tube.The gas delivery nozzles may be attached to a small cannula whichextends to the ventilator. The inner diameter of the tubes and theannular space between the nozzles and tubes may be dimensioned to matchthe airflow resistance of the nose, or to increase the resistance amaximum of 10%. This may be done by widening the area of the tube wherethe nozzle is located, and by minimizing the length of sections of thetube that are less than the effective inner diameter of the nasalpassage. The cannula can also include a lumen for pressure sensingwithin the tubes, so that the nasal breathing pressure can be measured,and this sensing lumen can extend closer to the nostril entrancecompared to the gas delivery nozzle tips. The two tubes 8601, 8603 maybe curved to direct the proximal opening and the gas delivery nozzle tothe side of the nose away from the center of the mouth. Therefore, theuser may be able to use their mouth for normal functions while thetherapy is being used because the airflow going in and out of the tubesis not in the way of the mouth. The tubes may typically be joinedtogether with an interconnecting member that can allow for spacingadjustment of the tubes or angular adjustment of the tubes. The tubesand or the interconnecting member may have a cushion attached to theposterior side to space and align the tubes correctly with respect tothe nostrils as will be explained subsequently. The tube curvature maybe shaped to optimize the convenience to the user and to stabilize theapparatus to the face of the user to avoid inadvertent shifting. Theapparatus may be secured to the face by straps 8609 that are connectedto either the interconnecting member or the tubes. Alternatively, thecannula attached to the gas delivery nozzle can be used to secure theapparatus to the face. The proximal opening of the tubes mayalternatively may include a muffler to reduce dampen sound, and thenozzle-tube relationships can include geometries, materials and surfacecharacteristics to reduce sound generation as described previously.

The outer tubes 8605, 8607 may be sized to contact the inner wall of thenostril. The outer tubes can be radially expanding to allow it mate witha range of nasal dimensions, or can be tapered to mate with a range ofdimensions, or can be of a fixed dimension. The outer tube can also beprovided in multiple sizes for it to be compatible with a range ofanatomical sizes. The outer tube can optionally be surrounded with acompliant compressible material that compresses when inserted into thenostril so that the outer tube is held in place in the nostril with alight amount of interference tension, for example less than 0.5 lbs oftension.

In the example shown in FIG. 82, the outer tube is shown curved todirect the exiting gas in an anatomically correct pathway. Forsimplicity, the figures throughout may be shown with the jet nozzle andouter tube with straight centerlines, or in a view in which thecenterline is straight, however, it should be noted that a straightdepiction is exemplary only, and that the jet nozzles and outer tube canbe straight, angled or curved, or combinations thereof, to optimize fitand gas flow dynamics. Additional details of the jet pump features,shapes and dimensions are described in subsequent descriptions.

FIGS. 83-85 show various embodiments of a schematic cross sectionthrough the nasal interface described in FIG. 82, indicating the nozzleproximal to, distal to, or coplanar with the proximal opening of thetube, respectively. For simplicity the cross sections are shownstraight, however, the structure is preferably curved as shown in theisometric view in FIG. 82. In addition, the outer tubes can be curved orangled from front to back to match the angle of the nostril.

FIG. 83 shows a jet pump inlet and entrainment zone 8709 that may beformed in a nostril rim and opening 8701, nostril wall 8703, nostrilforamen 8705, and/or nasal septum 8707. In FIG. 83, a nasal interface8711 may include a jet pump nozzle 8713 outside an outer tube 8715. Theouter tube 8715 may have a jet pump throat 8717 and a jet pump diffuser8719.

In FIG. 84, an entrainment chamber 8709 may form between the nozzle 8713and the outer tube 8715 when the nozzle 8713 is partially inserted intothe outer tube 8715. As shown in FIG. 84, the outer tube 8715 may bedimensioned such that it is smaller than the nostril, enabling thepatient to breathe spontaneous air around the outside of the outer tube,as well as through the inside of the tube. In the example shown, the jetnozzle distal tip may be positioned inside the outer tube, in thetransition zone region where the outer tube transitions in diameter fromthe inlet to the throat. The nozzle tip location can be located anywherewithin this transition region, including coplanar with the inlet, andcoplanar with the start of the throat area, and alternatively, thenozzle tip can be proximal to the inlet.

In FIG. 85, the tip of the nozzle 8713 may be substantially flush withthe proximal end of the outer tube 8715. As seen in the cross sectionalschematics in FIGS. 83-85, the outer tube 8715 may include a jet pumpinlet and throat. The patient may be permitted to breathe room airspontaneously through the outer tube. The entrainment area 8709 of thejet pump may be the area proximal to the outer tube proximal end. Theouter tube can be whole or partly inserted into the nostrils. The outertube may also serve to align the jet nozzle and overall jet pumprelative to the nostrils, and may also serve to position and secure theinterface to the patient's nose and face. As described in FIG. 85 theouter tube may include a widening at its distal end to serve thefunction of a jet pump diffuser. The diffuser may help create a laminargas flow exit profile, and improves the efficiency and overall power ofthe jet pump. In the example shown, the nozzle distal tip may becoplanar with the outer tube inlet, however, the distal tip can beplaced in other locations, including proximal to the inlet, and recessedinside the outer tube.

FIGS. 86-93 show another embodiment of the invention.

FIG. 86 shows an overall view of a nasal ventilation interface 9000. Theinterface 9000 may include a ventilator connector 9001, a gas deliverycircuit portion 9003, a cannula portion 9005, a distal end portion 9007designed to be placed at, in or proximal to the entrance to thenostrils, a cannula jet nozzle 9009 at or near the distal tip of theoverall assembly, optionally an outer tube 9011 concentric about thedistal tips of the cannula jet nozzle as shown, or alternatively amanifold, an attachment and positioning pad 9015 at the distal end, anadjustment member 9013 at the distal end to adjust the position andangulation of the distal end cannula nozzles 9009, and to adjust thelocation relative to the nostril opening, and a spontaneous respirationsensor 9017.

FIG. 88 describe a more detailed side view of the distal end of thenasal interface 9000 shown in FIG. 86. The cannula jet nozzle 9009 mayor may not be located within or concentric to an outer tube 9011 aspreviously described. Pressure or flow sensing ports 9201 may be locatedon the distal end 9007 of the cannula 9005 near the nozzle 9009, and anairflow or pressure sensor 9017 may be located on the outer tube 9011,either on the inner or outer wall of the outer tube. The flow sensingports 9201 may be in communication with one or more sensing lumens 9203.A diffuser 9205 may be located at a distal end of the outer tube 9011.The cannula 9005 and/or outer tube 9011 may be attached to theattachment and positioning pad 9015 and the attachment and positioningpad 9015 may include a nostril locating tab extension 9019 that extendssuperiorly and which is used to position the distal end of the assemblyproperly below and optionally slightly inside the nose. A head strap9021 may be provided to secure the overall assembly to the head andface, and is typically connected to the attachment and positioning pad,although it can be attached to the cannula or outer tubes as well.

FIG. 87 describes an exemplary cross section of the cannula of the nasalinterface at line A-A indicated in FIGS. 86 and 88. Optional featuresare shown, such as a second sensing lumen 9101 (in the case two sensinglumens are used to derive airflow, or in the case that two sensinglumens are used to correct for the effects of the Venturi or as aredundancy), a humidity delivery lumen 9103, a drug delivery channel9105, an external sensing tube 9107 positioned on the outside of thecannula in the case that breath sensing is performed with a separatetube, and a transmission wire 9109 for an additional breath sensingelement such as a piezoelectric, a thermal sensor, or other types ofsensing elements. A ventilation gas delivery lumen 9111 may be withinthe outer tube 9011.

FIG. 89 shows a front view of an alternate embodiment of a distal end ofa nasal interface. The distal ends of the cannula or nozzles 9301 may beconnected to outer concentric tubes 9303 with a slot or bracket to alignthe nozzles 9301 with the outer concentric tubes 9303. The nozzle distaltips 9301 are shown concentrically inside the outer tubes, however,could be coplanar with the outer tubes entrance or proximal to the outertubes. An interconnecting length adjustment coupler 9305 may attach thetwo outer tubes together. The coupler 9305 can be adjusted to set thespacing between the outer tubes to the desired dimension, to fit theanatomy of the individual user. A connecting pad 9307 may be attached tothe cannula-outer tube-coupler assembly. The attachment between thecoupler and the outer tubes can include a swivel connection 9313 torotate or adjust the angle of the outer tube in at least one plane, sothat the outer tubes can be aligned properly with the individual'sanatomy, to optimize fit, comfort and function. The angle of the outertubes can also be adjusted to lightly pinch the nasal septum to helpsecure the assembly in place in the user's nose. A head strap or headfastener 9309 may fasten the assembly's distal end to the user's headand face. The strap or fastener 9309 can be a fabric, plastic or metalmaterial, or combinations thereof. In this as well as the otherembodiments, a cannula 9311 can optionally be comprised of a rigid orsemi-rigid tubular material, which can also serve the role of the headfastener. The rigid or semi-rigid material can be attached to the outertubes such that the nozzle is positioned relative to the outer tubes asdesired. The semi-rigid tubular material can be for example a rigidplastic such as nylon, or a metal alloy which extends from theventilation gas delivery hose to the distal tip of the nozzle. Portionsof the cannula can be backed with a soft material such as a fabric orfoam to make it comfortable against the skin. A cannula connection slot9331 may couple the cannula 9311 to the outer tubes 9303 or connectingpad 9307. The outer tubes 9303 may include a jet pump diffuser 9315, ajet pump throat 9317 and a jet pump inlet chamber 9319.

FIG. 90 shows a front view of an alternate embodiment of the distal endof the nasal interface. A cannula 9401 may be connected to outerconcentric tubes 9303 with a slot or bracket, and nozzles 9301 may beincluded at the distal tip of the cannula 9401. The nozzle distal tips9301 are shown concentrically inside the outer tubes 9303, however,could be coplanar with the outer tubes entrance or proximal to the outertubes. An interconnecting length adjustment coupler 9403 may attach thetwo outer tubes together. The coupler 9403 can be adjusted to set thespacing between the outer tubes to the desired dimension, to fit theanatomy of the individual user. A head fastener 9309, which canoptionally be an extension of the coupler, attaches to the outer tubesand may be used to attach the assembly to the head and face. The headfastener 9309 also optionally includes a portion that connects to thecannula 9401.

FIG. 91 describes a front view of an alternate embodiment of the distalend of the nasal interface, similar to the embodiments described inFIGS. 89 and 90. Breath sensing ports 9501 and lumens 9503 may beincluded in the outer concentric tubes 9303. The lumens 9503 can beintegral to the construction of the outer tubes, or can be coupled tothe outer tubes, or can be a separate tube. The sensing lumens 9503 maybe used to measure the pressure or flow signal generated by thepatient's spontaneous breathing. Additionally or optionally, a sensor9505 can be placed somewhere outside of the outer tubes, for example ona coupler 9507 as in the example shown. The sensor can be a thermalsensor, or some other type of sensing element as described subsequently.In the example shown the sensor would be positioned outside of andinferior to the nostrils, however, the sensor could be located insidethe nostril or directly at the entrance to the nostril. Alternatively,one nostril could be used for sensing while the other nostril is usedfor gas delivery. Sensors may communicate reading through a sensor wire9509 and/or a sensor tube 9511. A cannula 9513 may deliver ventilationgas.

FIGS. 92 and 93 describe an alternate embodiment of a jet pump 9601portion of the distal end of the nasal interface. In FIG. 92, a fullisometric view of the jet pump is shown and FIG. 93 describes thevarious sections of the jet pump. In this embodiment a jet nozzle 9701can be physically coupled to an outer tube or throat 9703 by aconnection and alignment bracket 9705 as shown, or by a directconnection, or by another component such as an attachment pad aspreviously described. A cannula 9707 may lead to an entrance 9709. Theentrance 9709 may lead to a throat inlet 9711, the throat 9703, and adiffuser 9713. The jet nozzle tip internal diameter may have a varietyof geometries. For example, it may have a restricted diameter toincrease gas flow linear velocity at the very tip, or can include auniform inner diameter for a distance of at least 3-5 times the internaldiameter, or can be flared. The assembly of the nozzle and outer tube orthroat can be fastened to the nose and face by a variety of methods; forexample, the throat can be inserted into the nose with an interferencefit or with a frictional fit, and the nozzle is positioned and alignedby the position of the throat. Alternatively, the throat can be held inplace by the attachment pad as previously described, or can be held inplace by a face or head strap, for example a strap that attaches to thepad or throat, and extends to the back and/or top of the head. Or,alternatively the cannula leading to the nozzle can be held in place andfastened to the user by a head strap fastened to either the cannula orattachment pad with a strap or fastener that extends to the back and/ortop of the head. Other attachment configurations described elsewhere canalso be used. Dimensional values of the jet pump features may varydepending on the patient size, the selected ventilator flow and pressureoutput, the patient type, the disease, and the level of the therapydesired.

FIGS. 94 and 95 show an alternative embodiment in which the gas deliverynozzles are provided in a manifold 9801 that includes compliant nostrilinserts 9803. The manifold 9801 may include multipleentrainment/breathing apertures 9805. A gas delivery nozzle can bepositioned to direct the gas directly through the nostril inserts intothe nostril, or can be positioned lateral to the nostril inserts inwhich case the manifold that may include a curved gas flow path curvingfrom the gas delivery nozzle to the nostril inserts.

FIGS. 96 and 97 show another embodiment in which the gas delivery tubes10001 may attach to a manifold 10003 in a mid-section of the manifold10003, to generally align the gas delivery nozzles with the nostrilinserts, rather than the gas delivery tubes attaching to the sides ofthe manifold. Sides 10005 of the manifold 10003 may include openings10007 to ambient air.

FIGS. 98 and 99 show an embodiment where a distal tip of the interfaceincludes an inner nozzle and concentric outer tube jet pumpconfiguration. FIG. 98 shows a side view of this embodiment in which thenasal interface 10201 comprises concentric inner and outer tubes 10203,in which case the outer tube may be sized to contact the inner wall ofthe nostril. The outer tube can be radially expanding to allow it tomate with a range of nasal dimensions, or can be tapered to mate with arange of dimensions, or can be of a fixed dimension. In FIG. 99, theouter tube 10203 is shown curved to direct the exiting gas in ananatomically correct pathway. Other configurations are possible.

The outer tube can also be provided in multiple sizes for it to becompatible with a range of anatomical sizes. The outer tube canoptionally be surrounded with a compliant compressible material thatcompresses when inserted into the nostril so that the outer tube is heldin place in the nostril with a light amount of interference tension, forexample, less than 0.5 lbs of tension.

FIGS. 100 and 101 show an embodiment where a low profile nasal interface10401 may be attached to the exterior of the nose. The nasal interface10401 may serve two functions: first, the nasal interface 10401 can beused to connect the nasal interface 10401 to the face, and position andlocate a cannula 10403 correctly, and second, the nasal interface can beused to prevent distention of the nostril wall when the ventilation gasis delivered, in the cases in which a high level of therapy is beingdelivered. In addition to the nasal interface, a mouth seal can be usedwith the invention, or a head band to keep the mouth closed, forexample, when a mouth breather uses the therapy when sleeping (notshown). The nasal interface 10401 may have a shell 10405, a nozzle10407, a coupler 10409, a gas delivery circuit 10411, and/or a connector10501.

Table 3 provides exemplary dimensions and materials for variousembodiments of the present invention. These are only exemplary and otherdimensions and materials may be used for various situations.

TABLE 3 Exemplary Dimensions, Values and Materials of the InventionPreferred Feature Range Range Dimensions Gas delivery hose, ID (mm)2.0-7.0 2.5-4.5 Gas delivery hose, Length (ft), ambulating with wearablesystem 2-6 2.5-4   Gas delivery hose, Length (ft), ambulating withstationary system 20-75 40-60 Gas delivery hose, Length (ft), sleeping 4-15  6-10 Cannula, ID (mm) 0.5-5.0 2.0-3.0 Cannula Length (in)  5-20″ 8-12″ Jet Nozzle, ID (mm) 0.25-2.0  0.05-1.75 Jet Nozzle, Length (mm)1.0-30   4-12 Jet Nozzle distance to nose, Nozzle inside manifold design(mm) 5-60 mm 15-40 mm Jet Nozzle distance to nose, Nozzle inside outertube design ⁻5-60 mm 5-50 mm Jet Nozzle distance to nose, Nozzle in freespace design (mm) ⁻2-40 mm 5-30 mm Manifold Length (mm) 20-160 mm 30-80mm Manifold throat cross sectional area (in2) .015-.080 .025-.050Manifold Pillow opening CSA (in2) .040-.120 .065-.105 Manifold pressuresensing line diameter (in) .015-.055 .025-.045 Manifold BreathingAperture CSA (in2) .035-.095 .050-.080 Should be 1.125 to 3.0 times thesize of the Manifold throat cross sectional area, preferably 1.75-2.25times the size Manifold sound reducing return vent CSA (in2) .002-.050.005-.020 Should be 1/10^(th) to ¼^(th) the size of the manifoldbreathing aperture Manifold breathing resistance (cmH2O @ 60 lpm) 1-41.5-2.5 Breathing resistance, outer tube design (cmH2O @ 60 lpm) 1-41.5-2.5 Breathing resistance, free space design, distance to nose (cmH2O@ 60 lpm) 0-2 0-1 Breathing sensing port, free space design, distance tonose (mm) ⁻5-10 ⁻2-5   Breathing sensing port, manifold or outer tubedesign, distance to nose −5-30  0-20 (mm) Outer Concentric Tube, OD (mm) 5-20  8-14 Outer Concentric Tube, Inlet max ID (mm)  3-12 5-8 OuterConcentric Tube, Inlet length (mm)  4-15  6-12 Outer Concentric Tube,Throat ID (mm)  3-12 5-9 Outer Concentric Tube, Throat Length (mm)  3-20 8-12 Outer Concentric Tube, Diffuser outlet ID (mm)  3-12  7-11 OuterConcentric Tube, Diffuser length (mm)  2-10  6-10 Spacing between jetnozzle tip and pump inlet (+ value = proximal to; − 30 mm to −15 mm 10mm to −5 mm value = recessed. Pump inlet may be outer tube, or may benostril rim) Attachment and Positioning Pad; 20-80 × 1.0-10.0 × 40-60 ×3.0-6.0 × L × D × H (mm)  6-35 12-24 Coupler, L 5-25 mm 7-10 mm Coupleradjustment range 6-25 mm 8-10 mm Angle adjustment in front plane betweennozzles and/or outer tubes Parallel to 5-20 degree 45degree includedangle included angle Materials Types Preferred Gas delivery hose PP, PE,PS, PE PVC Cannula PU, PVC, PVC, Silicone Silicone Manifold PVC, PVC,Silicone Silicone, PU, PE, Polysolfone Jet Nozzle Metal, PVC Ultem,Nylon, LCP, PVC, PC, ABS, PEEK Outer Concentric Tube or Pillows PVC,Silicone Silicone, PS Attachment and Positioning Pad Silicone, SiliconeFoam Coupler Metal, Metal and Nylon, PVC, Silicone Silicone Manifold gasvolume (cubic inches)| .050-.400  .075-.200: Dimensions listed areexemplary and for average sized adults; pediatric sizes 20% less,neonatal sizes 50% less. Diameters listed are effective diameters(average cross sectional dimension)

The various embodiments of the present invention may have variabletechnical details and parameters. The following are exemplary technicaldetails and parameters that may be use. These are not meant to belimited, but are merely for illustrative purposes.

For jet nozzles located in free space, such as those of FIGS. 8-58, thefollowing may apply:

1) Dimensions/Relationships

-   -   a. A jet nozzle diameter 17201 and distance from a nare opening        17203 may provide that a jet profile 17205 is substantially the        same diameter as the nare 17203 when entering the nare 17203,        see FIG. 166.    -   b. The jet nozzle 17201 preferably may be placed concentric to        the nare 17203 for maximum performance, although this        configuraiton may increase noise in some situations.

2) Materials

-   -   a. A simi-rigid elastomer may be used for patient comfort.    -   b. A majority of the sound generated by these configurations may        be from the mixing of the high velocity jet with the low        velocity entrained air at the nare opening. Material selection        most likely does not have an affect on sound.

3) Exit Velocity

-   -   a. Exit velocity perferably is maximized sonic flow to create as        large of a jet flow rate as possible. Limitations may include        ventilator source pressure limitations and peak delivered flow        requirements.

4) Entrainment/Flow Amplification

-   -   a. In these configurations, total flow can be up to four times        or more the augmented flow.

5) Pressure Generation

-   -   a. Values of approximately 17 cmH2O (@0 inspiratory flow) have        been observed.

6) Sense Ports

-   -   a. The sense ports may be as proximal to the nare opening as        possible. Preferably the mask may slightly occlude the nare        opening so that a sense port located between the occlusion and        the nare opening may sense the pressure drop due to the        occlusion during an inspiratory effort.

For jet nozzles coaxially located in nasal pillows, such as those ofFIGS. 59-81, FIG. 167 illustrates one potential positioning of a jetnozzle 17301 relative to a nasal pillow diameter 17303. A jet profile17305 may be substantially the same diameter as the nasal pillow 17303when entering the nasal pillow 17303.

For jet nozzles coaxially inside a manifold lateral to the nose, such asthose of FIGS. 82-99, the following may apply:

1) Dimensions/Relationships

-   -   a. A jet diameter 17401 and a distance from the jet to an end of        a throat section 17403 may be configured such that a jet profile        17405 substantially equals the throat diameter at the entrance        to the throat section, as shown in FIG. 168. Another acceptable        extreme may be when a jet diameter 17501 and a distance from the        jet to an end of a throat section 17503 may be configured such        that a jet profile 17505 is substantially the same diameter as        the throat when entering just before exiting the throat section,        as shown in FIG. 169.    -   b. Jet may be placed concentric to the throat for maximum        performance, although this configuration may be louder than        other configurations.    -   c. Jet may be placed near tangent and at a slight angle for        maximum noise attinuation without significant reduction in        performance.    -   d. The path of the throat section may be fairly straight without        significant changes in area and direction. This may apply up to        a location where the jet profile area equals the throat        diameter. Beyond this critical point the geometry may be more        organic.

2) Materials

-   -   a. A simi-rigid elastomer may be used for patient comfort.    -   b. A simi-rigid elastomer may also be helpful in attinuating any        noise generated in the manifold section of the nasal interface.

3) Exit Velocity

-   -   a. Exit velocity preferably may be maximized sonic flow to        create as large of a jet flow rate as possible. Limitations to        this rule may be ventilator source pressure limitations and peak        delivered flow requirements.

4) Entrainment/Flow Amplification

-   -   a. In these configurations, total flow can be up to four times        the augmented flow.

5) Pressure generation

-   -   a. Values of 25 cmH2O (@0 inspiratory flow) have been observed,        but values of 30 cmH2O or more may be possible.

6) Sense Ports

-   -   a. The sense ports may be located between the entrainment        opening in the mask and the nasal pillow. The entrainment        opening may provide a differential pressure for the sense ports        to measure.    -   b. If the throat section is configured to neck down for        increased pressure capacity, then it may be preferable to place        the sense port between this necking and the nasal pillow. This        may increase the differential pressure available for the sense        port.

In various embodiments of the present invention, a nasal interface mayhave ventilation gas jet nozzles that are substantially further from thenose than breathing sensors. Jet nozzles more distant than breathsensors may allow for improved gas flow profiles entering the nose,while still allowing for accurate and sensitive breath measurementsbecause the sensors are close to the inlet and outlet of the nose.

The nasal interface may typically be provided in a kit. For example, twolengths of gas delivery hoses, 3-5 sizes of outer tubes, and 2-3 sizesof manifold assemblies may be provided so that the user can select thesizes appropriate for his or her anatomy, and assemble the componentstogether into a complete assembly.

FIG. 102 is a block diagram describing an exemplary system of theinvention with a non-invasive open nasal interface 10600. A ventilatormodule 10601 may include or is in communication with several otheraccessories or functional modules. A transmitter 10603 may be includedto transmit information regarding the patient, the patient's therapy,and the ventilator performance to a remote location for review,analysis, remote intervention, two way communication, and archival. Forexample, the patient's compliance to the therapy or utilization of thetherapy can be monitored and assessed. Important information can betrended, for example the patient's breath rate, I:E ratio or depth ofbreathing. Also, information can be sent to the ventilator, for exampleprogramming of settings to titrate the ventilator output to meet theneeds of the patient.

An internal or external humidifier 10605 can be included for extendeduses of the therapy, or if using in dry climates. In addition to anoxygen source 10607, a compressed air source 10609 can be included,typically external attached to the ventilator module 10601, howeveroptionally internal to the ventilator module 10601 if the therapy isbeing used for stationary use, for example in the home. A blender 10611can be included to control the fractional delivered O2 in a gas deliverycircuit 10613, and a pulse oximeter 10615 can be used in order todetermine the correct blender setting in order to achieve the properoxygen saturation. The pulse oximeter can also be used to titrate theother settings of the ventilator system to meet the physiological needsof the patient. In addition to compressed supplies of oxygen and airgas, the ventilator can include internal or external air and oxygengenerating systems 10617, such as a compressor, pump or blower to createpressurized air, and an oxygen generator and/or pump to createpressurized oxygen gas, and a compressed gas accumulator. The oxygensource can also be liquid oxygen, or a liquid oxygen generating system.Because the therapy is frequently used to help activities of dailyliving, and to promote activity, a pedometer 10619 and/or actigraphysensor 10621 can be included internal to or external to a ventilatormodule 10601. A CO2 sensor 10625 may also be included and/or anotherexternal sensor 10637 an/or a breathing sensor 10643. A CO2 sensing line10639 and/or an airway pressure sensing line 10641 may be present. Anexternal respiration sensor or respiration effort sensor 10627 can beincluded, such as a respiratory muscle effort sensor, a chest impedancesensor 10635, or other types of sensors, such as a tracheal or othermicrophone or vibration or acoustical or ultrasonic sensor. The externalsensor is used either as a redundant sensor to the nasal airflow ornasal pressure sensor 10629, or to complement the information obtainedfrom the nasal airflow sensor, or in place of the nasal airflow sensor.A drug delivery module 10631 can be incorporated internally orexternally to a ventilator 10633. Because of the challenges with currentaerosolized drug delivery inhalers, the system can be used to propel anddeposit medication particles deep in the respiratory system without acarrier propellant. Because the patient's using the therapy often mayalso require prescription medication, this may be a convenient andefficient way to administer the medication.

When the therapy is being used for respiratory support, the user mayhave two options: (1) wearing or toting the ventilator so that the usercan be ambulatory or enjoy the activities of daily living, or (2)stationary use, in the event the patient plans on being stationary ordoes not have the ability to ambulate. For the later, the deliverycircuit can optionally be provided in a 25-100 foot length, such thatthe gas source and ventilator can be stationary in the patient's home,while the patient can move around their home while wearing the interfaceand receiving the therapy. Or, the gas source can be stationary, andconnected to the ventilator with a 25-100 foot hose, so that the patientcan wear or tote the ventilator and be mobile within the range of thehose.

FIG. 103 describes an optional embodiment when the invention is intendedfor hospital or institutional use, in which a gas delivery circuit 10701may be connected to a blender 10703, which receives pressurized oxygenand pressurized air from the hospital pressurized gas supplies, such ascompressed O2 10705 and compressed air 10707 from systems that may beattached to a wall 10709. The gas supply may pass from the blender 10703to a flow control 10711. An airway pressure sensing line 10713 may bepresent. An open interface 10715 may include an open nasal interface, anET tube interface, an open oral interface and/or an open transtrachealinterface. In this application, in which mobility may be less important,the system can be attached to the house gas supply, and higher levels oftherapy can be delivered, as well as PEEP therapy during exhalation. Allof these different options of stationary use and mobile use apply to thevarious different interface techniques described in the foregoing.

Delivering humidity can sometimes be useful when using the therapydescribed in this invention. The humidity can be delivered using ahumidification generator that is integral or coupled with theventilator, or using a stand alone humidifier. The humidified air oroxygen can be delivered through the gas delivery channel of the gasdelivery circuit, or through another lumen in the gas delivery circuitas previously described, or through a separate cannula or tubing. Forextended use, when the patient is likely to be stationary, thehumidification system can be a stationary system and capable ofdelivering a relative high amount of humidity, and for periods ofmobility, the patient can either not receive humidification, or use aportable humidification system that is capable of delivering relativelya small amount of humidity, due to size and energy consumptionconstraints.

The therapy described in this invention can be used with a variety ofgas sources. For example, when treating respiratory insufficiency suchas COPD, the gas source of choice is oxygen-rich gas, for example from acompressed oxygen cylinder or wall source, a LOX dispensing device, oran oxygen concentrator. In the event the patient requires some, butless, O2, both an oxygen and air source can be used as input into theventilator, and a blender used as previously described to titrate theamount of O2 needed, either based on a clinical determination, or bypulse oximetry or other biofeedback signals. Alternatively, theventilator can receive a compressed supply of one of either oxygen orair, and the other gas can be entrained into the gas delivery circuit orventilator. If air is entrained in, it can be entrained in from roomair. If oxygen is entrained in, it can be entrained in from for examplean oxygen concentrator or LOX dispenser or oxygen liquefaction system.For sleep apnea applications, however, supplemental oxygen may not beneeded, and hence the ventilation system uses a source of compressedair, or an air generating source. Also, neuromuscular diseases maysimilarly require only air. As described previously, combinations of gasdelivery can be used, for example, a continuous delivery of oxygen canbe administered, for example 2 LPM to provide proper oxygenation, and asynchronized volume delivery of gas can be delivered during inspirationto provide the mechanical support. This modality can be used to titratethe FIO2 and oxygen saturation needed. For treating other diseases andapplications, other therapeutic gases can also be delivered by blendinginto the delivered gas, such as helium-oxygen mixtures, nitric oxide, orcombinations of air, oxygen, helium and nitric oxide.

To facilitate integration of this new ventilation therapy into theexisting therapeutic paradigms, a convertible system may be used.Specifically, the patient interface can be modular, such that a patientcan be administered conventional oxygen therapy with a typical orslightly modified oxygen nasal cannula. Then, when it is desired toswitch the patient to this new ventilation therapy, an additionalcomponent such as the outer concentric tube, or manifold, or breathsensing port, may be added to the nasal cannula to create the jet pumpdesign and to position the distal tips of the cannula properly toachieve the function of this invention, while still maintaining breathsensing. Or for example, a switch on the gas delivery equipment can beswitched to change the output of the equipment from oxygen therapy, tothis therapy, by for example, enabling additional breath sensingfunctions, timing functions, waveform functions, and switching to theoutput amplitude necessary. Modular features such the portions of theequipment can be used for both COPD during daytime use, and sleep apneaduring sleeping, are contemplated in the invention with the appropriatemodularity and docking stations.

While the foregoing has described the therapy of this invention using anasal interface, other interfaces may also be included in the invention.In FIG. 104, the therapy is described using a trans-oral interface10801. A cannula 10803 may be secured to the patient with a neck strap10805. The tip of the catheter can be proximal to the mouth entrance,coplanar with the mouth entrance, or recessed inside the mouth betweenthe lips and the awe line. The catheter can be shaped to be routed alongthe teeth, either on the buccal side or lingual side of the teeth, orthrough the center of the mouth. The catheter can be positioned so thata portion of the catheter rests on the superior surface of the tongue,or can be positioned so that a portion of the catheter rests against theinferior surface of the hard palate, in which case the distal tip of thecatheter may be angled or curved inferiorly away from the palate andtowards the oropharyngeal airway. The catheter can be bifurcated so thatthere is a left and right catheter positioned on both the right and leftside of the mouth. The catheter can be integral to a bite block or mouthguard. The catheter is easily inserted and removed from the patient'smouth. All of the appropriate details described previously inconjunction with the nasal interface may apply to the oral catheter usedin this version of the invention. While an intra-oral catheter ormouthpiece is shown in FIG. 104, the invention can also be a mouthpiecethat barely enters the mouth, or a nasal-oral mask that can provide thetherapy to both the nasal airway and the oral airway, with theappropriate breath sensors determining if the patient's month is open toadjust the therapy as needed.

FIG. 105 shows an embodiment used with an ET tube interface 10901. Thisversion of the interface can be helpful to institutions which walk theirpatients during the weaning stages off of invasive mechanicalventilation. Walking patients whom are on ICU ventilators is typicallyvery onerous because the patient must have the assistance of a number ofmedical staff to move the large and complex ICU ventilator along sidethe patient. In FIG. 105, the present invention may be used to help apatient walk, while receiving adequate ventilatory support form theventilation system and interface described in this invention. In thisembodiment, the ET tube connector may include an attachment for theventilation interface. The patient can breathe ambient air spontaneouslythrough the proximal end of the ET tube proximal connector which is leftopen, while the patient's spontaneous breaths are efficaciouslyaugmented by the ventilation system, gas delivery circuit 10909 andcatheter interface 10901. Optionally, in addition if it is desired toapply PEEP, a special PEEP valve 10903 may be included for attachment tothe end of an ET tube 10905. The special PEEP valve may include a oneway valve so that ambient air is easily entrained into the ET tubetoward the patient's lung by a jet nozzle 10907, but also allowsexhalation through the PEEP valve 10903, while maintaining the desiredPEEP level. The patient can still also breathe room air spontaneouslythrough the PEEP valve through an inspiratory valve integral to or inparallel with the PEEP valve. For PEEP application, alternatively theventilator used in the present invention can provide PEEP as previouslydescribed by delivering gas with the appropriate waveform during thepatient's expiratory phase. The catheter tip can be slightly proximal tothe proximal end opening of the ET tube proximal connector, or can becoplanar with the proximal end opening, or can be inserted into the ETtube to the appropriate depth, typically at around the mid-point howeverwhich will depend on other variables of the system. The depth can beadjustable to optimize the entrainment and performance or function forindividual situations, as required clinically or for patient tolerance.The ET tube connector used in this embodiment of the invention may be ofa special unique configuration that provides the necessary jet pumpgeometry as previously described in conjunction with the nasal cannulaouter concentric tube. The connector can include a jet inlet, jet throatand diffuser section. Or, alternatively, the ET tube can be of a specialconfiguration, which incorporates dimensions and geometries advantageousto the jet pump performance. All of the appropriate details describedpreviously with the nasal interface, apply to the ET tube catheterinterface used in this version of the invention. In addition, PEEP canbe included in the other patient interfaces described in the inventionby including a similar special PEEP valve designed for each of thedifferent patient interfaces.

FIG. 106 is a system block diagram of the components of a ventilator V,minus the optional modules and accessories described earlier. Theventilator can be self contained with a battery and gas supply to enableit to be borne by the patient, so that the patient can ambulate andparticipate in activities of daily living, which is made possible by therespiratory support they are receiving from the ventilator, but in apackage that can easily be borne.

FIGS. 107-164 show various therapeutic aspects of the present inventionin more detail. For the therapy described in this invention to be moreeffectively titrated to the needs of the patient, the ventilator systemcan perform an analysis to determine the level of respiratory supportneeded. To accomplish this, the ventilator can titrate the output to theneeds of the patient, for example during ambulation or activity, theoutput can increase. Alternatively, during higher respiratory rates asmeasured by the spontaneous breath sensor, the output can increase.Alternatively, during higher breath effort as measured by the breathsensor, the output can increase. Other biofeedback signals can be used.In addition to the output increasing or changing to meet the respiratoryneeds of the patient, the timing of the ventilator output relative tothe patient's spontaneous inspiratory phase, and the output waveform,can change to meet the comfort and physiological needs of the patient.For example, during exercise, the output can change from an earlydelivery at 75 ml with an ascending waveform, to being triggered with adelay to start for example 100 msec after the start of inspiration, andwith a decelerating waveform.

When the patient is attaching the patient interface when starting atherapeutic session, the breath sensors can be used to determine properpositioning of the distal tip of the interface relative to the patient'snostrils. For example, if the jet nozzles and or outer concentric tubesare not aligned properly, the sensor may detect less entrainment thanexpected, or detect that a certain pressure signal characteristic ismissing, and the signal may initiate an alert to be communicated to thepatient, caregiver or clinician through the ventilator user interface,or through remote monitoring. Once the alignment and positioning isproper, the alert may disable and the ventilator may inform the patient,caregiver or clinician that the interface is positioned properly.Similarly, during a therapeutic session, if at any time the interface isimproperly positioned, the sensors can detect the low entrainment valuesor the wrong characteristic signal, and using that signal the system cansend the notification or alert to the patient, caregiver or clinicianthat a repositioning is required. The detection of entrainment valuescan be accomplished by including flow or pressure sensors near the tipsof the jet nozzles or coupled with the concentric outer tubes, which mayregister entrained ambient airflow movement past the sensing elements orsensing ports, as previously described. Special configurations of theinterface assembly can include sensor locations in which at least onesensor is biased toward registering spontaneous breathing by thepatient, while at least one other sensor is biased toward registeringentrained ambient airflow. This configuration allows the system todistinguish between spontaneous breathing and entrainment, such thatentrainment does not mask the breathing signal. Alternatively, thesensor can register predominantly entrainment during the time whenventilator output is active, and register predominantly spontaneousbreathing when the ventilator output is off.

FIG. 107 describes how the patient's work of breathing may bebeneficially affected by the invention, when the invention is used forlung disease or neuromuscular disease applications. The patient's lungvolume may be graphed as a function of lung pressure, the area insidethe curve representing work, typically expressed in Joules per Liter(J/L), and for a normal healthy adult can be 0.3-0.6 J/L. For arespiratory compromised patient, 4-10 times more work can be required tobreathe during rest, and even more during exertion, to overcome thediseased state of the tissue, for example to overcome static and dynamichyperinflation as in the case of COPD, or to overcome high airwaysresistance as in the case of fibrosis or ARDS. In the graph shown, thearea inside the curve below the pressure axis is the inspiratory WOB,and the area defined by the area inside the curve above the pressureaxis is the expiratory WOB. The arrows show the cycle of a singlebreathe over time, starting from RV to VT then returning from VT to RV.RV1 and VT1 are the residual volume and tidal volume without thetherapy. RV2 and VT2 are the residual volume and tidal volume with thetherapy. As can be seen, RV increases with the therapy because in thisexample, expiratory flow is provided as part of the therapy, which mayincrease residual volume. Importantly, VT is increased with the therapyand is increased more that the RV is increased, indicating that morevolume is entering and leaving the lung as a result of the therapy. Theincrease in tidal volume is considered clinically efficacious, howeveris technically challenging to achieve in an open ventilation,non-invasive and minimally obtrusive system. As is shown in the graph,the patient's inspiratory WOB with the invention ON may be about 25%less than the patient's inspiratory WOB with the invention OFF. Also,inspiratory lung pressure increases (is less negative) and tidal volumeincreases, and optionally exhaled pressure increases if the therapy isprovided during exhalation. While residual volume increases in theexample shown because the ventilator is providing gas in this exampleduring the expiratory phase, the ventilation parameters can be titratedto not effect residual volume, and because of the ability of the patientto exercise their lung muscles when receiving the therapy, the patient'slung mechanics may remodel in the case of COPD, actually causing areduction of residual volume to a more normal value. In the graph shown,the waveform with therapy assumes an early inspiratory trigger time forthe ventilator inspiratory phase therapy output, and that the volumeoutput is delivered within the patient's inspiratory time. Optionally,however, different delivery waveforms and delivery synchronizations canbe performed, which may adjust the WOB curve. For example, theventilator inspiratory phase therapy can be delivered late in theperson's inspiratory cycle, with delivery completing at the end ofinspiration, and delivered with a square or ascending waveform profile.In this case the WOB curve with therapy will be tilted upward to theright of the curve, such that Inspiration ends and transitions toExhalation at a point above the lung pressure zero axis.

FIG. 108 graphically illustrates the lung volumes achieved with a nasalinterface of the present invention on actual test subjects. Usingembodiments of the present invention, tidal volume may increase by anaverage of approximately 41%.

FIG. 109 graphically illustrates lung volumes achieved with a nasalinterface of the present invention on a test subject using a chestimpedance band to measure and display lung volume. To the left side ofthe graph, while spontaneously breathing the subject is receivingventilation from the invention, and on the right side of the graph, theventilation therapy may be turned off and the subject may bespontaneously breathing without the ventilation therapy, showing amarked increase the ventilation therapy causes over baseline, thusshowing how NIOV can increase lung volumes.

FIG. 110 graphically illustrates the lung volumes achieved with NIOV ona lung simulator bench model in comparison to conventional ventilation.In all the waveforms the simulated patient is spontaneously breathing atthe same inspiratory effort which results in a tidal volume of 245 ml,and the clinical goal is to increase the patient's tidal volume from 245ml 11001 to 380 ml 11003. In the first waveform 11005 from left to rightin the graph, the patient's breath is un-assisted and thus the patientreceives a tidal volume of 245 ml. In the next waveform 11007, thesimulated patient with the same effort is assisted with a traditionalclosed system ventilator, such as with a sealed breathing mask or cuffedairway tube. The ventilator output 11009 is set to a level in order toachieve the desired “assisted” tidal volume of 380 ml. The ventilator isset to 420 ml to achieve this goal. In the third waveform 11011, a smallleak is introduced in the conventional ventilator system, such as wouldbe done in the case of weaning the patient off of the ventilator. Toachieve the desired “assisted” tidal volume of 380 ml, the ventilatormust now be set at 705 ml 11013. In the second and third waveforms, itcan also be seen that all of the volume received by the patient's lungoriginates from the ventilator, which it must in these conventionalsystems. In the forth waveform 11015, the patient is assisted with theNIOV, and as can be seen, the NIOV ventilator output only has to be setat 90 ml 11017 to achieve desired “assisted” level of 380 ml. In thiscase, only some of the 380 ml tidal volume comes from the ventilator,and a substantial portion of the 380 ml comes from entrainment andspontaneously inspired ambient air, therefore making the NIOV system farmore efficient, comfortable, and healthier, than the other systems.

FIG. 111 graphically shows NIOV in comparison to oxygen therapy, usingthe lung simulator bench model. In the first waveform on the left 11101,the patient is unassisted and breathes at an effort of −0.8 cmH2O,generating 248 ml of inspired tidal volume. In the second waveform 11103and third waveform 11105, the patient receives continuous flow 11109 andpulsed flow 11111 of oxygen respectively via nasal cannula, with no ornegligible effect on lung pressure and tidal volume. In the forthwaveform 11107, NIOV 11113 is used which shows a marked increase in lungpressure and tidal volume, thus indicating that NIOV helps in thework-of-breathing as described earlier, despite the fact that NIOV is anopen airway system.

FIG. 112 includes two graphs that graphically describe a typical COPDpatient's ability to perform a 6 minute walk test using standard oxygentherapy and the NIOV therapy described herein. In the oxygen therapywalk (top graph), the patient fatigues early and has to stop to rest,because the amount of energy the patient has to expend to breathe toovercome their reduced lung function, is just too difficult. The patienthas to rest, and often sit down or lean against something. Typically,the heart rate and blood pressure are extremely elevated in addition tobeing fatigued, and the CO2 level is high because the patient cannot getenough air in and out, again, because of how much energy is required tobreathe. The same patient performing the walk test using NIOV (bottomgraph) may be able to walk the entire 6 minutes without walking, becauseNIOV is helping their respiratory muscles in the work of breathing. TheCOPD patient is typically able to walk 10-50% further with the NIOV, or30-70 meters further. Because NIOV is a wear-able system, and becausethe patient interface is an open airway interface, the patient may becomfortable with the ventilator and interface and is able to leave thehouse and perform activities of daily living.

FIG. 113A describes lung pressure generated by NIOV compared to lungpressure generated by a conventional CPAP ventilator. Each ventilator isdelivering flow through their respective gas delivery circuits and nasalmasks. The NIOV system is set for the ventilator to output 28 lpm, and,as explained above, it entrains additional gas from ambient air beforethe gas enters the patient's airways. The CPAP system is set to 20cmH2O, a relatively high but typical setting for CPAP therapy. When themask is occluded, the pressure generated by the system is indicated inthe graph at zero on the X axis. As can be seen the NIOV system iscapable of generating at least as much pressure as the CPAP system. Whenthe gas delivery circuits and masks are open to atmosphere, the NIOVsystem can generate 18 cmH2O easily while delivering approximately 55lpm of gas, which is well within the capability of the NIOV system.Therefore, with NIOV a Respiratory Insufficiency patient or a SleepApnea patient can be ventilated just as well as with CPAP; however, withthe convenience and minimal obtrusiveness of the NIOV system.

FIG. 113B describes lung volumes achieved with the NIOV system incomparison to conventional CPAP. The CPAP system is set to aninspiratory pressure of 10 cmH2O and expiratory pressure of 5 cmH2O. TheNIOV system is set to an inspiratory pressure of about 10 cmH2O, but isnot set with an expiratory pressure, and hence the expiratory pressureis that of the spontaneously breathing patient. Alternatively, asexplained earlier, the expiratory pressure with the NIOV system couldalso be set at a level elevated from spontaneous expiratory pressure. Ascan be seen in the graphs, the CPAP patient has an elevated RV becauseof the expiratory pressure and flow, whereas the NIOV patient has anormal RV. This can be very beneficial in COPD to preventhyperinflation, or in OSA to maximize patient comfort and tolerance.Note that the same therapeutic inspiratory pressure can be reached inboth cases.

FIGS. 114-153 graphically describe NIOV in more detail as it relates toproviding mechanical ventilatory support for the patient. FIGS. 114-129compare the invention with the prior art. FIGS. 114-117 compare deliverycircuit drive pressure of NIOV to the prior art. FIGS. 118-121 compareinspiratory phase volume delivery of NIOV to the prior art. FIGS.122-125 compare lung pressure of NIOV to the prior art. FIGS. 126-129compare typical outer diameter of a delivery circuit of NIOV to theprior art.

FIGS. 114-117 describe the pressure signal in the gas delivery circuitof the invention. The pressure range in FIGS. 114 and 115 are typicallyin the 5-40 psi range, and the pressure range in FIG. 116 is typicallyin the 0.1-0.5 psi range. The pressure range in FIG. 117 can be eitherin the 5-40 psi range or in the 0.1-0.5 psi range depending on the exacttherapy.

FIGS. 118-121 describe the volume delivered by prior art oxygentherapies, comparing NIOV to the prior art. This series of graphs showonly the volume delivered to the patient by the therapy, and do notdescribe the additional spontaneous volume being inspired by thepatient. The total volume being delivered to the lung is the combinationof the volume being delivered by the therapy and the volume beingspontaneous inspired by the patient, and in the case of NIOV the volumeentrained by the therapy. For the purpose of this description, the totalresultant lung volume is shown in the graphs in FIGS. 122-125, in termsof lung pressure, which is directly correlated to lung volume. The lungpressure resulting from the therapy is governed by a combination offactors: the gas delivery circuit pressure, the jet pump design andconfiguration, the patient's lung compliance and airway resistance, thetiming of the ventilator output relative to the patient's inspiratoryphase, and the ventilator output waveform. Typically, however, a gasdelivery circuit pressure of 30 psi delivering 100 ml with a squarewaveform, and delivered for 500 msec starting at the beginning of thepatient's inspiratory phase, may increase lung pressure by 5-15 cmH2O.And, typically a gas delivery circuit pressure of 30 psi delivering 250ml with a square waveform, and delivered for 500 msec starting at thenear the middle of the patient's inspiratory phase, may increase lungpressure by 10-25 cmH2O.

FIGS. 122-125 describe the effect that the therapies have on lungpressure. In FIG. 122, two potential lung pressure results caused by theinvention are both depicted: less negative pressure shown by the solidline and positive pressure shown by the dotted line. Additionalwaveforms and resultant lung pressures conceived by the invention areshown in subsequent figures.

FIGS. 126-129 graphically represent the relative cross sectional area orprofile required for the gas delivery circuits of the various therapies,providing an indication of the size and obtrusiveness of the interface.As can be seen by comparing the invention to pulsed dose oxygen therapy,for the same circuit delivery pressure conditions and an equal or evensmaller gas delivery circuit profile, the invention may produceentrained flow, whereas oxygen therapy has negligible entrained flow,and the invention may provide greater volume delivery, and causes anmechanical effect on lung pressure, compared to oxygen therapy which hasno effect on lung pressure. Comparing the invention with high flowoxygen therapy (FIGS. 116, 120, 124, 128), NIOV has the potential tohave an equal or greater effect on the lung pressure andwork-of-breathing, however with a significantly smaller delivery circuitprofile and with much less gas consumption. 15 LPM or more of source gasmay be consumed in the case of HFOT, whereas less than 8 LPM of sourcegas may be consumed in the case of NIOV, this making the invention atleast equally efficacious, but with a more efficient design. For thesake of comparison, the volume depicted in the curve in FIG. 120accounts for and describes the volume output of the HFOT system onlyduring the patient's inspiratory time, even though the output iscontinuous flow as indicated in FIG. 116. Comparing NIOV with BiPAPventilation therapy, the invention can approximate the effect on thelung that BiPAP therapy produces (FIGS. 121 and 125); however, with asignificantly less obtrusive delivery system, and with a system that ispotentially wearable and permits activities of daily living. FIG. 125shows a range of lung pressures that can be created by BiPAP, rangingfrom the solid line to the dotted line.

FIGS. 130-153 graphically show different alternative ventilator outputwaveforms of the present invention, and the effect of the ventilatoroutput on the patient's lung mechanics. The series of graphs in FIGS.130-133 and 142-145 indicate a pressure waveform in the deliverycircuit. The series of graphs in FIGS. 134-137 and 146-149 indicate thevolume delivery, both delivered and entrained. The series of graphs inFIGS. 138-141 and 150-153 indicate a pressure level in the lung.

FIG. 130 describes a square pressure waveform output during thepatient's spontaneous inspiratory phase, which entrains ambient air atapproximately a 1:1 ratio effectively doubling the volume delivered tothe patient, and resulting in an increase in lung pressure duringinspiration from a negative pressure (when therapy is off) to a positivepressure (when therapy is on). FIG. 131 describes a rounded pressuredelivery waveform, delivered during inspiration after a slight delayafter the start of the inspiratory phase. The entrained air volume maybe roughly equal to the ventilator output, and the resultant lungpressure may be increased from its normal negative value duringinspiration to a positive value. The lung pressure may return to normalat the end of the gas delivery, to the patient's normal value.Alternatively, the waveform duration can be extended so that it endscoincident with the start of exhalation, or slightly into exhalation,such that the lung pressure remains positive when transitioning frominspiration to exhalation. FIG. 132 describes a square pressure outputwaveform delivered and completed in the first portion of the inspiratoryphase, and completed before the transition to exhalation. In this casethe lung pressure may be affected and becomes positive, and may returnto its normal level when the ventilator delivery is completed.

FIGS. 133, 137 and 141 describe a multiple pressure amplitude deliverywaveform, with a higher amplitude delivered during inspiration andtransitioning to a lower amplitude delivered during exhalation. Twopotential resultant lung pressure waveforms are both shown in FIG. 141,the solid line showing a relatively high pressure during exhalation,such as a PEEP pressure of 3-10 cmH2O, and the dotted line showing anattenuating and less pressure during exhalation, such as a pressure of1-5 cmH2O. Delivered volume may be increased due to the entrainment asin the other waveform examples. Lung pressure may be increased duringinspiration (less negative pressure is shown, however, zero pressure orpositive pressure is also possible), and during exhalation positivepressure is maintained and or increased beyond the patient's normalexpiratory pressure. The positive pressure during exhalation can helpreduce dynamic hyperinflation by reducing airway collapse duringexhalation, and or can help alveolar ventilation and lung recruitment,by keeping the lung lobule spaces biased open during all phases ofbreathing including the expiratory phase. While the example shows twodiscrete pressure levels, there may be multiple levels, or a variablelevel that adjusts as needed, and the transition from one level toanother can be ramped rather than stepped as shown.

FIGS. 142, 146 and 150 describe an ascending pressure delivery waveformin which the pressure begins to be delivered at the onset ofinspiration, and ramps up during the delivery period. The deliveryperiod can be a portion of inspiratory phase, or all of inspiratoryphase, or longer than inspiratory phase, depending on the clinical needand the comfort of the patient. The ramping waveform serves to match thepatient's spontaneous breathing, such that the intervention feelscomfortable and synchronized with the patient's demand, effort and need.Less gas may be entrained when using this waveform compared to someother waveforms, however, the total delivered volume is sufficient toincrease lung pressure to a positive pressure if desired.

FIGS. 143, 147 and 151 describe a descending waveform, which may bepreferred if the patient is breathing deep or heavy, such that theinitial strong demand from the patient is matched with a strong outputfrom the ventilator.

FIGS. 144, 148 and 152 describe a multiple pressure amplitudes deliverywaveform, delivered within inspiration. The first pressure amplitudewhich is lower, comprises oxygen rich gas, such that the residence timeof the oxygen in the lung is maximized to improve oxygenation anddiffusion, and the second pressure amplitude which is higher and whichcan comprise just air or air/oxygen mixtures or just oxygen, is used tocreate a mechanical effect on pressure in the lung to help mechanicallyin the work of breathing. The second boost also serves to help theoxygen delivered in the first boost to penetrate the lung moreeffectively.

FIGS. 145, 149 and 153 describe an oscillatory multiple deliverywaveform in which the pressure delivery is oscillated between off andon, or between a higher and lower value. This alternative waveform canimprove gas source conservation and may have other beneficial effects,such as comfort and tolerance, entrainment values, penetration, drugdelivery and humidification.

It should be noted that with respect to the ventilation system gasdelivery waveforms shown in FIGS. 130-153, aspects or the whole of onewaveform can be combined with aspects or the whole of another waveform.Also, the amplitude and timing values may vary. For example, theventilator gas flow delivery can commence immediately at the beginningof inspiration or can commence with a delay or can be timed to besynchronized with a certain portion of the patient's inspiratory phase,such as when the inspiratory flow or inspiratory muscle effort reaches acertain percentage of maximum. Or, for example, the delivery can bewithin the inspiratory time, equal to the inspiratory time, or extendbeyond the inspiratory time. Or, for example, the pressure created inthe lung by the ventilator can be less negative than baseline(ventilator off), or zero pressure can be created, or positive pressurecan be created, or combinations of less negative, zero and positivepressure can be created. The different waveforms can be combined andmixed, for example, pressure delivery can be delivered during exhalationin combination with an ascending pressure waveform being deliveredduring inspiration. In an optional embodiment of the invention, theventilation gas delivery rate is selected to attempt to match to thepatient's inspiratory demand. When the patient is breathing deeper andstronger, the ventilation output may be increased to match the demand.When the patient is breathing shallower and weak, the ventilation outputmay be decreased to match the need. In an optional embodiment, this flowrate matching can be used to create a zero pressure or close to zeropressure condition in the lung during inspiration, or alternatively,create a certain desired negative pressure, such as −2 cwp, or to createa certain desired positive pressure, such as +2 cwp. A biofeedbacksignal can also be used to titrate the ventilator output to the need ofthe patient, for example such as respiratory rate, depth of breathing aspreviously mentioned, walking or activity level, or oxygen saturation.In an additional embodiment, the sensor arrangement at the tip of thecannula can include the capability to measure and record the absolute orrelative amount of entrained ambient air. Based on a collection ofmeasurements such as nasal airway pressure, and other known values suchas ventilator gas output parameters, the ventilation system can togetherwith the entrained ambient air measurement, determine the total amountof gas being delivered and being spontaneous inspired into the patient.From this information tidal volume and FIO2 can be derived, and theventilation status of the patient ascertained and the setting of theventilator further titrated for improved efficacy.

Ventilation can be delivered in synchrony with inspiration, or insynchrony with exhalation, or both, or can be delivered at a highfrequency, a constant flow, in a retrograde direction, and all possiblecombinations of the above. When synchronized with the patient'sinspiratory or expiratory phase, the ventilator (V) may deliver volumein ranges from approximately 40-700 ml per cycle, preferablyapproximately 75-200 ml, in delivery times of approximately 0.2 to 1.2seconds, preferably approximately 0.35-0.75 seconds, and with a catheterexit speed of approximately 50-300 m/sec., preferably approximately150-250 m/sec. If delivered at a high frequency rates, the ventilator(V) may deliver volume at a rate of approximately 0.25 cycles per secondto approximately 4 cycles per second, preferably at a rate ofapproximately 0.5 to 2 cycles per second, in the range of approximately10 ml to 100 ml per cycle, preferably approximately 25-75 ml per cycle.When delivered at a constant flow, the ventilator V may deliver flow ata rate of approximately 0.5 LPM to 10 LPM, preferably approximately 2-6LPM, and at a catheter exit speed of approximately 50 m/sec to 250m/sec, preferably approximately 100-200 m/sec.

Optionally, high frequency low volume ventilation can be delivered bythe ventilator and patient interface where very low volumes of gas aredelivered at very fast frequencies, such as approximately 5-50 ml atapproximately 12-120 cycles per minute, or preferably approximately10-20 ml at approximately 30-60 cycles per minute. In this manner,substantial minute volumes can be delivered to the lung but whilecontrolling the pressures achieved in the airway and lung more closelyto a desired level, albeit in an open airway system. This deliverywaveform can be continuous, or can be synchronized with the inspiratoryphase of breathing. Again, different waveforms described can be combinedin whole or in part, for example, volumes can be synchronized anddelivered in one shot during inspiration, and then high frequency lowvolume ventilation can be delivered during exhalation. It should also benoted that ventilation gas delivery, when activated, can gradually rampup so that it is not a sudden increase in amplitude, which could arousethe patient.

Further, as shown in FIG. 165, NIOV can include speaking detectioncapability, such as using airway pressure signal processing or sound orvibration sensors, and when speaking is detected, the ventilator outputcan switch from synchronized delivery during inspiratory phase, toeither no delivery or continuous flow delivery, so that the ventilationgas delivery is not out of synchrony with the patient's breathingpattern. Also, the system can include a pause feature, so that thepatient can speak, or eat, with the therapy off, for example for 10-20seconds. The pause feature can turn the therapy output to zero, or to acontinuous flow.

It should be noted that in the graphical examples provided, therespiration sensor waveform is exemplary only and actual waveforms cantake on other characteristics, such as different I:E ratios, breathrates, random behavior, ascending and descending shapes of inspiratoryand expiratory curves, and altering amplitudes. It is noted that becauseof the gas flow delivery from the cannula, a region of transientnegative pressure may be generated near the catheter distal tip. Thesensing signal processing may take this into account when determiningthe breath phase.

The current invention is also an improvement over existing sleep apneaventilation therapies. The present invention may prevent or reduceobstruction of the airway, or alternatively may ventilate the lungduring a complete or partial obstruction, with a cannula-based systemthat is less obtrusive than CPAP, thereby improving patient adherence,compliance and efficacy of the therapy. In addition, the invention mayprovide improved prediction of the onset of an apneic episode so thatthe therapy can intervene in a more precise, intelligent manner and amanner that is more tolerant to the patient. Embodiments of the presentinvention may include one or more of the following features: (1)catheter-based synchronized ventilation of the oropharyngeal airwayand/or lung; (2) catheter-based pressurization of the oropharyngealairway to prevent or reverse airway obstruction; (3) using breathingeffort and breathing sensors for apnea prediction and detection and forregulating the therapeutic parameters; (4) using a minimum amount ofventilation gas to treat OSA, thereby creating less noise and providinga more normal breathing environment; (5) a ventilation deliveryinterface that is minimized in size to improve tolerance and comfort;(6) an open system so that the patient can feel like they are inhalingand exhaling ambient room air naturally.

FIGS. 154-161 graphically describe the ventilation parameters and theireffect on respiration air flow, when the invention is used to treatsleep apnea SA. Similar parameters and techniques are used to treatobstructive sleep apnea (OSA) central sleep apnea (CSA) and mixed sleepapnea (MSA). FIGS. 154-156 illustrate the three basic treatmentalgorithms of the present invention used to detect and treat OSA:reaction/correction, preemption, and prevention, respectively. FIG. 154describes intervening upon detection of apnea. FIG. 155 describesintervening upon detection of a precursor to an obstruction to prevent acomplete obstruction. FIG. 156 describes intervening proactively inattempt to prevent obstructions. In this series of graphs, t is the timeaxis, Q is the airway flow signal, IQ is the inspiratory flow signal, EQis the expiratory flow signal, VO is the ventilator output, 32 is thenormal breathing flow curve, 34 is a breathing flow curve when theairway is partially obstructed, and 48 is an obstructed airflow signaland 40 is the ventilator output synchronized with the actual breath, and44 is the ventilator output based on previous breath history orbreathing effort. In the examples shown, the ventilation is delivered insynchrony with the patient's inspiratory breath effort, however this isexemplary only, and ventilation can also be delivered using constantflow or pressure, or variable flow or pressure, or any combination ofthe above. Additional details of the treatment algorithms are explainedin subsequent descriptions.

In FIG. 154, the reaction and correction algorithm, the spontaneousbreathing sensor may detect a shift in nasal airflow from a normalairflow signal 32 to a reduced airflow signal 34. As seen in the graphlabeled “with intervention”, immediately after the reduced airflowsignal 34 is detected by the breathing sensor or, alternatively, aftersome desired delay, the gas delivery control system commands theventilator to deliver ventilation flow/volume 44 at a rate based on pastbreath rate history. The ventilator gas flow together with ambient airentrainment may open the obstruction and restore respiration as seen inthe graph labeled “with intervention” and restore ventilation to thelung. For contrast, the graph labeled “without intervention” shows therespiration signal eventually going to no airflow signal 48, thusindicating a substantially complete obstruction. In the example shown,during the period of partial or complete obstruction, the flow signal atthe nares is not strong enough for the breathing sensors to detectrespiration. Alternatively, during apnea, the ventilator gas flow can bedelivered from the ventilator at a pre-determined back-up rate, ordelivered as a continuous flow. In FIG. 155, the preemption algorithm,the breathing sensor detects a shift in nasal airflow from a normalairflow signal 32 to a reduced airflow signal 34. Either immediately orafter some desired delay, the control unit may command the ventilator todeliver ventilator gas flow synchronized with inspiration 40.Alternatively, the ventilator gas flow can be delivered at apre-determined back-up rate, or at a continuous flow. In FIG. 156, theprevention algorithm, ventilator gas flow is delivered in synchrony withthe patient's spontaneous breathing, and when a reduction in airflow 34occurs due to the onset of an obstruction, the cyclical rate of theventilator prevents the obstruction from fully developing, and thebreathing returns to normal 32. While the ventilator gas flow profilesdescribed in FIGS. 154-155 indicate discrete gas volume outputs withintermittent delivery, other gas delivery profiles can exist, such ascontinuous flow and combinations of volume deliveries and continuousflow delivery, as will be describe in more detail subsequently. Itshould be noted that the three basic algorithms can be combined in wholeor in part to create a hybrid treatment algorithm.

FIG. 157 graphically shows the patient and ventilator waveforms over aperiod of time, in which the ventilator is activated during theprecursor to an apnea 34 or during periods of apnea or airwayobstruction 48, and then is deactivated when normal breathing 32 isrestored. The ventilator gas flow may be delivered cyclically whenactivated, as shown, or as described earlier can be deliveredcontinuously. In an optional embodiment of the invention the ventilatorcontrol system includes a database describing the characteristic breathsensor signal waveforms or amplitudes or frequencies (collectivelyreferred to as waveforms) that relate to the different phases of sleep.For example the database includes characteristic waveforms for an awakestate, an S1, S2, S3 and S4 sleep state, and an REM state. Theventilator control system would compare the actual measured waveformwith this database of characteristic waveforms. The ventilator wouldthem make determinations to designate breaths as “apnea” breaths, versus“normal” breaths, versus “partial obstruction” breaths, versus othersituations like snoring, coughing, etc. This feature would further allowthe ventilation output treatment algorithm to be matched to the needs ofthe patient. For example, the algorithm in which the ventilator outputis enabled during the detection of an onset of an apneic event, i.e., apartial obstruction, can then differentiate between a partialobstruction and simply a lighter stage of breathing. Alternatively,instead of a database, these characteristics could be determined in realtime or learned by the ventilator. Or, alternatively, an additionalsensor can be included in the invention which measures the stages ofsleep, such as an EEG sensor or biorhythm sensor. In addition, theinvention can include artifact detection and screening, so that themonitoring of the patient's status and control of the therapy is notfooled by an artifact. Such artifact detection and screening include forexample snoring or breathing into a pillow.

The breath detection may be critical to the function of the inventionwhen used to monitor and treat forms of SA. In OSA for example, during apartial obstruction, gas flow at the nares may be reduced due to theobstruction. The tracheal pressure signal may increase because of theincreased pressure drop required to move air across the partialobstruction, or because of moving gas flow back and forth between thetrachea and lung. Conversely, airflow at the nares reduces or stops.Therefore, an apneic event can be detected by the loss of a pressure offlow signal being measured at the nares, and a precursor to an apneicevent is detected by a reduction in the signal amplitude. Using both apressure and airflow sensor may be desired because the information canbe crosschecked against each other, for example, a reduced airflowsignal plus an increased pressure signal may correspond to the precursorof an obstruction event. In addition, another external respirationsensor may be used to detect respiratory muscle effort, such as a chestimpedance or chest movement sensor. In this case, the effort signal maybe compared to the nasal airflow and/or nasal pressure signal, and thecomparison can determine exactly what the breathing condition is amongall the possible conditions, for example, normal unobstructed breathing,partially obstructed breathing, complete obstructions, heavyunobstructed breathing and light unobstructed breathing. Also, OSA canbe distinguished from CSA events particularly if using both a nasalsensor and muscles sensor, and comparing the signals. An external sensorcan optionally be used in place of the nasal air flow sensor as theprimary respiration sensor.

FIGS. 158-164 describe different gas flow delivery waveforms, ortreatment algorithms, when the invention is used to treat OSA. Thedelivery waveforms can be used with each of the three basic treatmentalgorithms described earlier, i.e., reaction/correction, preemption, andprevention, or a hybrid of the three treatment algorithms. In each case,the ventilator gas output may be disabled when the user first connectsthe mask and gets in bed, and only when needed later when the patient isasleep or drowsey or after a period, does the ventilator gas outputenable, thus allowing the patient to breathe freely through the maskwithout any therapy at the beginning of the night, to make the patientfeel completely normal. Since the mask is a completely open mask, thisis possible, whereas this is not possible with conventional CPAP andBiPAP sleep apnea masks and breathing circuits. The graphs labeled Qrepresent airflow in the airways, and the graphs labeled VO representthe ventilator gas output, either in pressure or in flow or volume. InFIG. 158, the ventilator output is increased 40 in response to aweakening airflow or breathing signal 34, thus preventing obstructionand restoring normal airflow 32. The ventilator output returns to itsbaseline amplitude at the desired subsequent time. In FIG. 159, theventilator output switches from a synchronized cyclical on and offoutput 40 to delivering a continuous flow 47 between cycles, when theonset of an obstruction 34 is detected. In FIG. 160, the ventilatoremits a continuous flow or pressure output 42 until the precursor to anapnea 34 is detected, at which time the ventilator boosts its output todeliver a greater amplitude of pressure, flow or volume synchronizedwith inspiration, while the reduced airflow 34 representing the partialobstruction is present. In FIG. 161, a variable ventilator pressure orcontinuous flow or pressure output 42 is delivered, which ramps 43 to agreater amplitude until the reduced airflow signal 34 is returned to anormal signal, after which time, the ventilator output can ramp down toits baseline value. In a preferred embodiment indicated in FIGS. 160 and161, the ventilator output can ramp up from zero output, extending tothe left of the scale shown in the graphs, when the user first attachesthe interface and is awake, to a very small output when he or she fallsasleep, and ramp to an increased output when the onset of an apneicevent is detected, or, ramp from zero to a higher output only when theapneic onset is detected as described using a combination of FIG. 155and FIG. 161. This capability is a significant advantage overconventional OSA PAP therapy in that the patient can comfortably andnaturally breathe ambient air past or through the NIOV nasal interfacewhen awake but in bed, and before the apneic or hypopneic breathingbegins, without the ventilation gas being delivered. This is difficultand ill advised with conventional PAP therapy in which the patientbreathes the significant majority of gas through the mask and hose, inwhich case it is best to always have the ventilation gas being deliveredto the patient to prevent CO2 retention in the hose, mask and airwaysdue to rebreathing. Other gas flow delivery waveforms are included inthe invention, and the above ventilator output waveform examples can becombined in whole or in part to create hybrid waveforms or switchingwaveforms. For example, the ventilator output can be small gas volumesdelivered in synchrony with inspiration, until the precursor to anobstruction is detected at which time the volume output is increased; ifthe obstruction gets worse or becomes completely obstructed, then theventilator output switches to continuous flow which ramps from astarting amplitude to higher amplitudes until the obstruction is opened.

FIGS. 162 and 163 indicate additional treatment algorithms, specificallya continuous flow ramping algorithm and an inspiratoryeffort-synchronized algorithm respectively.

In FIG. 162 ramping is conducted during inspiratory phase only to makethe increase more unnoticeable to the patient. The ventilator outputramps to a low-level non-therapeutic flow prior to ramping to thetherapeutic flow, for the purpose of acclimating the patient to thefeeling and sound of the therapy, and ramps during inspiration in orderto minimize the sensation of increasing flow to the patient.

FIG. 163 indicates an algorithm in which non-therapeutic pulses of floware delivered in synchrony with the patient's inspiratory effort, inorder to condition or acclimate the patient to the feeling and or soundof the therapy. In addition, delivering non-therapeutic levels of gasearlier in the session also serves to provide information to the systemregarding the fit and function of the nasal interface. For example, ifthe interface is attached correctly, the system will detect that andproceed normally, but if the interface is not attached or alignedcorrectly, the system will detect this with signal processing, and canalert the user to make adjustments before the patient enters a deepstage of sleep. Alternatively, the system can provide therapeutic levelsof therapy soon after the nasal interface is attached, and determine ifthe interface is connected properly, and if not, instruct the patient tomake the necessary adjustments. Once properly fitted, as determined bythe signal processing of the system, the ventilation gas output isturned off until needed, as described in the foregoing. Alternatively,the breathing pressure signal can be used to ascertain if the interfaceis attached and aligned properly.

FIG. 164 graphically illustrates in closer detail an optional embodimentof the gas delivery waveform when using an inspiratoryeffort-synchronized therapy.

For SA treatment, some additional or alternative parameters are asfollows: Volume delivery can be approximately 10 ml to 200 ml perventilator cycle depending on the breathing status of the patient. Ifcomplete apnea occurs, volume delivery increases to approximately 200 mlto 500 ml per cycle, at a rate of approximately 6-20 cycles per minute.The flow rate of the gas being delivered is typically approximately 6-50LPM during the actual delivery of the gas, and preferably approximately10-20 LPM. Timing of the ventilator cycling can be in synch with thepatient's breath rate, for example, approximately 6-30 BPM, or if notsynchronized or if the patient is apneic, cycling can be approximately8-20 cycles per minute unless high frequency low volume ventilation isused, which is described subsequently. The drive pressure at theventilator output for the ventilation may be typically approximately5-60 psi and preferably approximately 8-40, and most preferablyapproximately 10-15 psi, to create a desired oropharyngeal pressure ofapproximately 0-5 cmH2O under normal unobstructed conditions duringinspiration and up to approximately 20 cmH2O during obstructedconditions. It should also be noted that while ventilator gas flow isoften shown in synchrony with a breath cycle, the breath cycle may notbe detectable due to a partial obstruction or apneic event, and,therefore, the ventilator gas flow is simply applied at a predeterminedrate or a predicted rate. It should also be understood that depending onthe sensor used, the breath effort may still be detectable even thoughthere is no or very little airflow being inspired from ambient or beingexhaled to ambient. However, the movement of air in the trachea inresponse to the breath effort in some cases, depending on the sensortechnology being used, may be enough to register as an inspiratoryeffort and expiratory effort by the sensor. In fact, in some cases,depending on the sensor used, an obstruction may be accompanied by anincreased negative pressure during inspiration, and, while there isreduced airflow in the trachea T because of the obstruction, the breathsignal may be stronger. Therefore, in the present invention, the gasdelivery control system and algorithms in the gas delivery controlsystem takes all these matters into account while processing the sensorinformation and deciding whether there is normal or reduced breathingtaking place at any given time. The ventilation pressures achieved inthe upper airway by the delivery of the ventilator gas flow may be inthe range of approximately 1-20 cmH2O, preferably approximately 2-5cmH2O when delivered preemptively, and approximately 5-10 cmH2O whendelivered in response to a detected obstruction event. The ventilationpressures achieved in the lower airways and lung may be similar to thepressures achieved in the upper airway by the ventilation gas delivery.

Optionally, high frequency low volume ventilation can be delivered bythe ventilator and patient interface, where very low volumes of gas aredelivered at very fast frequencies, such as approximately 5-50 ml atapproximately 12-120 cycles per minute, or preferably approximately10-20 ml at approximately 30-60 cycles per minute. In this manner,substantial minute volumes can be delivered to the lung but whilecontrolling the pressures achieved in the airway and lung more closelyto a desired level, albeit in an open airway system. This deliverywaveform can be continuous, or can be synchronized with the inspiratoryphase of breathing. Again, different waveforms described can be combinedin whole or in part, for example, volumes can be synchronized anddelivered in one shot during inspiration, and then high frequency lowvolume ventilation can be delivered during exhalation. It should also benoted that ventilation gas delivery, when activated, can gradually rampup so that it is not a sudden increase in amplitude, which could arousethe patient.

In an optional embodiment, the methods and apparatus of the presentinvention can be used to treat OSA by determining a flow raterequirement needed to prevent airway obstructions, rather thandetermining and titrating a therapeutic pressure level as is done inexisting systems. For example, a patient with a sleep apnea indexgreater than 10, or a negative inspiratory force of −10 cwp, or acertain upper airway compliance as determined by ultrasound or othermeans, a diagnostic measurement can be correlated to a therapeuticventilation flow rate requirement that may prevent, preempt or correctan obstruction or onset of an obstruction. The correlation can be madeautomatically by the ventilation system for each user, or can be made inadvance by a medical assessment.

It should be noted that in the graphical examples provided, therespiration sensor waveform is exemplary only and actual waveforms cantake on other characteristics, such as different I:E ratios, breathrates, random behavior, ascending and descending shapes of inspiratoryand expiratory curves, and altering amplitudes. It is noted that becauseof the gas flow delivery from the cannula, a region of transientnegative pressure may be generated near the catheter distal tip. Thesensing signal processing may take this into account when determiningthe breath phase.

It should be noted that the different embodiments described above can becombined in a variety of ways to deliver a unique therapy to a patientand while the invention has been described in detail with reference tothe preferred embodiments thereof, it will be apparent to one skilled inthe art that various changes and combinations can be made withoutdeparting for the present invention. Also, while the invention has beendescribed as a means for mobile respiratory support for a patient, itcan be appreciated that still within the scope of this invention, theembodiments can be appropriately scaled such that the therapy canprovide higher levels of support for more seriously impaired and perhapsnon-ambulatory patients or can provide complete or almost completeventilatory support for non-breathing or critically compromisedpatients, or can provide support in an emergency, field or transportsituation. Also, while the invention has mostly been described as beingadministered via a nasal interface it should be noted that theventilation parameters can be administered with a variety of otherairway interface devices such as ET tubes, tracheostomy tubes,laryngectomy tubes, cricothyrotomy tubes, endobronchial catheters,laryngeal mask airways, oropharyngeal airways, nasal masks, trans-oralcannula, nasal-gastric tubes, full face masks, etc. And while theventilation parameters disclosed in the embodiments have been mostlyspecified to be compatible with adult respiratory augmentation, itshould be noted that with the proper scaling the therapy can be appliedto pediatric and neonatal patients. Further, while the target diseasestates have mostly been described as respiratory insufficiency and SA,other breathing, lung and airway disorders can be treated by the therapywith the requisite adjustment in ventilation parameters, for example,ALS, neuromuscular disease, spinal cord injury, influenza, CF, ARDS,lung transplant bridging, and other diseases can be addressed with thistherapy, as well as mass casualty, pandemic, military, bridge andtransport applications. Lastly, while the invention has been describedas a stand alone therapy, the therapy can be modular, for example aventilation system can be adapted which can switch between invasive orNIV or other closed system ventilation modes and the non-invasive openventilation mode described herein. Or, the therapy can be usedsimultaneously in conjunction with other modes of ventilation, such asduring a conscious sedation medical procedure in which the patient isventilated with a conventional ventilator as a back up means ofrespiration while the patient receives ventilation from the modedescribed herein.

In general, any of these interface devices may include one or more ofthe following design or feature elements: Noise reduction elements,diagnostic element(s) for positioning the mask, sensing flow, volume,sensing augmentation, sensing entrainment—(knowing how much entrainmentis passing through the mask), incorporating the sensing ofeffort—sensing what the patient effort is, and feeding into patientdiagnostic to help diagnose different forms of respiratory problems,Apnea back up or apnea detection. The system could react to theinformation it's gathering, Could analyze entrainment, etc., feedbackfor correct fitting, positioning, i:e ratio), detection that the maskneeds to be adjusted due to fit, Congestion; Mustaches, facial hair;Plugged nose, etc.; Eating, Sneezing, Motion.

These devices, method and systems may also include the following andaddress the following problems: Adjusting the triggering sensitivitylevel, multi-axis pressure transducer capable of having more gain tohandle motion of the device better; additional sensors such as bloodpressure integral to the mask; temperature integral to the mask such asmeasuring temperature inside of the nose; speaker/microphone forcommunication; Video monitor for communication, customizing the mask orventilator to unique physical shape; integrating part of the system intoassisted walking devices for example attachment to walker, etc. Fortitration to the patient, an acquired signal obtained from the patientcould autotitrate by determining quickly their best trigger time andwaveform and matching the patient effort which may be important forcompliance. Diagnostic capability could include monitoring and capturingcoughing/sneezing. During sleep the system can monitoring sleepposition. The system can include sensors to distinguish between mouthbreathing and nose breathing and alert the patient to perform purse-lipbreathing if it is detected that they are active and not breathingright. The system can include an element that helps the patient bycoaching them through the different types of breathing/etc. The start upupon power on may gently ramp to the therapeutic level to avoidstartling patient. The system could optimize adjustment by sound, usinga microphone that detects when there is not optimal entrainment andpositioning. An audiofile could play from the ventilator. The ventilatorcould record breathing/wheezing, speech, lung sounds. The gas jets couldbe fabricated to create a helical gas stream exit to reduce sound andincrease power. Could play WAV files—of soothing therapist voice, etcwith volume of the music triggered to biofeedback (based on themental/anxiety state). There could be custom voice alert messages andinstructions. There could be active noise cancelling. The mask could befitted with pads on the sides of the nares—the pads can comprise Nitinoland could anchor the device. The ventilator could include an parts orreplacement supply ordering communication feature, as well as a panicbutton or trouble button. The nasal pillows may insufflate that providethe seal, position the device to center it based on the velocity, allowto float and location. Jets can come in from the bottom and from thesize. The system can include flesh-toned tubing and parts. There can be‘skins” for the system—personalize or individual system covers, etc.Additional sensors include glucose, blood pressure, electrolytes. Theventilator screen can include a mirror or camera and display to allowthe user to adjust the mask. The video can record the mask fit. Theventilator can include GPS for safety and other reasons and haveautomatic communication to a remote location for dealing with problems.Wax can be used to help fit the mask. The mask can include a modularshield to help performance in windy situations. The pillow can beinflatable to center with nostril. Ventilator skins can be personalizedand selectable from range of styles, mix/match, etc. The mask may havemultiple jets that converge/direct flow for each nostril.

Although the foregoing description is directed to the preferredembodiments of the invention, it is noted that other variations andmodifications will be apparent to those skilled in the art, and may bemade without departing from the spirit or scope of the invention.Moreover, features described in connection with one embodiment of theinvention may be used in conjunction with other embodiments, even if notexplicitly stated above.

1. A non-invasive ventilation system comprising: a nasal interfacecomprising a left outer tube comprising a left distal end adapted toimpinge a left nostril, at least one left opening in the left distal endin pneumatic communication with the left nostril, a left proximal end ofthe left outer tube in fluid communication with ambient air, and whereinthe left proximal end of the left outer tube curves laterally away froma midline of a face; a right outer tube comprising a right distal endadapted to impinge a right nostril, at least one right opening in theright distal end in pneumatic communication with the right nostril, aright proximal end of the right outer tube in fluid communication withambient air, and wherein the right proximal end of the right outer tubecurves laterally away from the midline of the face; one or more left jetnozzles for directing ventilation gas into the left outer tube, whereinthe one or more left jet nozzles are in fluid communication with thepressurized gas supply; and one or more right jet nozzles for directingventilation gas into the right outer tube, wherein the one or more rightjet nozzles are in fluid communication with the pressurized gas supply.2. The system of claim 1, wherein the one or more left jet nozzles, theone or more right jet nozzles, or both are directed toward an inner wallof the left outer tube, the right outer tube, or both.
 3. The system ofclaim 1, wherein the left outer tube and the right outer tube comprise ajet pump throat and a jet pump diffuser.
 4. The system of claim 1,wherein the one or more left jet nozzles are flush with an entrance ofthe left outer tube and the one or more right jet nozzles are flush withan entrance of the right outer tube.
 5. The system of claim 1, whereinthe one or more left jet nozzles are within an entrance of the leftouter tube and the one or more right jet nozzles are within an entranceof the right outer tube.
 6. The system of claim 1, wherein the one ormore left jet nozzles are outside an entrance of the left outer tube andthe one or more right jet nozzles are outside an entrance of the rightouter tube.
 7. The system of claim 1, further comprising at least onesensing lumen.
 8. The system of claim 7, further comprising at least onesecondary sensing lumen.
 9. The system of claim 1, further comprising adrug delivery lumen.
 10. The system of claim 1, further comprising ahumidity delivery lumen.
 11. The system of claim 1, further comprising acoupler between the left outer tube and the right outer tube.
 12. Thesystem of claim 1, wherein the left outer tube swivels relative to theright outer tube.
 13. The system of claim 1, further comprising aventilator for delivering ventilation gas in synchrony with phases ofbreathing.
 14. The system of claim 1, wherein ambient air is entrainedthrough the outer tube.
 15. The system of claim 14, wherein theventilation gas and the entrained ambient air elevates lung pressure,elevates lung volume, decreases work of breathing or increases airwaypressure.
 16. The system of claim 1, wherein the left outer tube and theright outer tube are stabilized against a face.
 17. The system of claim1, further comprising a wearable ventilator and a portable gas supply.18. The system of claim 1, further comprising a ventilator, theventilator comprising a control unit, and wherein the control unitadjusts an output of the ventilator to match a patient's needs based oninformation from at least one sensor.
 19. The system of claim 1, furthercomprising a ventilator, the ventilator comprising a control unit, thecontrol unit comprising a speaking mode sensing system, and wherein thecontrol unit adjusts an output of the ventilator while the patient isspeaking to not be asynchronous with a patient's spontaneous breathing.20. The system of claim 1, further comprising a ventilator, theventilator comprising a control unit, the control unit comprising anapnea or hypopnea sensing system, and wherein the control unit adjustsan output of the ventilator based on apnea or hypopnea.
 21. The systemof claim 1, wherein the left outer tube or the right outer tubecomprises sound reduction features selected from the group of: asecondary aperture, a filter for the aperture, textured surfaces, amuffler, sound absorbing materials, an angled jet nozzle, non-concentricjet nozzle positions, and combinations thereof.
 22. A non-invasiveventilation system comprising: a ventilator; a gas delivery circuitcomprising a left gas path and a right gas path; and a nasal interfacecomprising a left outer tube receiving ventilation gas from at least onenozzle on a distal end of the left gas path and a right outer tubereceiving ventilation gas from at least one nozzle on a distal end ofthe right gas path; wherein the left outer tube and the right outer tubecurve laterally away from a midline of a nose.
 23. The system of claim22, wherein ventilation gas is directed toward an inner wall of the leftouter tube and the right outer tube.
 24. The system of claim 22, whereinthe at least one nozzle on the distal end of the left gas path is withinthe left outer tube and the at least one nozzle on the distal end of theright gas path is within the right outer tube.
 25. The system of claim22, wherein the at least one nozzle on the distal end of the left gaspath is flush with the left outer tube and the at least one nozzle onthe distal end of the right gas path is flush with the right outer tube.26. The system of claim 22, wherein the at least one nozzle on thedistal end of the left gas path is outside the left outer tube and theat least one nozzle on the distal end of the right gas path is outsidethe right outer tube.
 27. The system of claim 22, wherein the left gaspath and the right gas path are stabilized against a face.
 28. Thesystem of claim 22, further comprising a portable gas supply, andwherein the ventilator is portable.
 29. The system of claim 22, whereinthe ventilator comprises a control unit, and wherein the control unitadjusts an output of the ventilator to match a patient's needs based oninformation from at least one sensor.
 30. The system of claim 22,wherein the ventilator comprises a control unit, the control unitcomprising a speaking mode sensing system, and wherein the control unitadjusts an output of the ventilator while the patient is speaking to notbe asynchronous with a patient's spontaneous breathing.
 31. The systemof claim 22, wherein the ventilator comprises a control unit, thecontrol unit comprising an apnea or hypopnea sensing system, and whereinthe control unit adjusts an output of the ventilator based on apnea orhypopnea.
 32. The system of claim 22, wherein the left gas path or theright gas path comprises sound reduction features selected from thegroup of: a secondary aperture, a filter for the aperture, texturedsurfaces, a muffler, sound absorbing materials, an angled jet nozzle,non-concentric jet nozzle positions, and combinations thereof.
 33. Amethod of providing ventilation gas, the method comprising: providing anasal interface system comprising: a ventilator; a gas delivery circuit;at least one jet nozzle at a distal end of the gas delivery circuit; atleast one outer tube proximate to the distal end of the gas deliverycircuit for receiving ventilation gas from the at least one jet nozzle,and wherein the at least one outer tube curves laterally away from amidline of a nose; at least one sensor; measuring spontaneousrespiration with the at least one sensor; and activating the ventilatorto supply ventilation gas in synchrony with phases of breathing throughthe gas delivery circuit and to the at least one jet nozzle such thatthe ventilation gas entrains ambient air, wherein the ventilation gasentrains ambient air.
 34. The method of claim 33, wherein theventilation gas and entrained ambient air elevates lung pressure,elevates lung volume, decreases work of breathing or increases airwaypressure.
 35. The method of claim 33, wherein ventilation gas isdirected toward an inner wall of the at least one outer tube.
 36. Themethod of claim 33, wherein the at least one nozzle is within the atleast one outer tube.
 37. The method of claim 33, wherein the at leastone nozzle is flush with the at least one outer tube.
 38. The method ofclaim 37, wherein the at least one nozzle is outside the at least oneouter tube.
 39. The method of claim 33, wherein the nasal interfacesystem comprises a portable gas supply, and wherein the ventilator isportable.
 40. The method of claim 33, wherein the supply of ventilationgas is adjusted to meet the needs of a patient based on information fromthe at least one sensor.
 41. The method of claim 33, further comprisingdetecting speaking, and wherein the supply of ventilation gas isadjusted based on whether or not a patient is speaking.
 42. The methodof claim 33, further comprising detecting apnea or hypopnea, and whereinthe supply of ventilation gas is adjusted based on apnea or hypopnea.